Management of Hazard Group 4 viral haemorrhagic fevers and similar human

Transcription

Management of Hazard Group 4 viral haemorrhagic fevers and similar human
Management of Hazard
Group 4 viral haemorrhagic
fevers and similar human
infectious diseases of high
consequence
Advisory Committee on Dangerous Pathogens
November 2014
Title: Management of Hazard Group 4 viral haemorrhagic fevers and similar human
infectious diseases of high consequence
Author: Directorate/ Division/ Branch acronym / cost centre
Advisory Committee on Dangerous Pathogens
Document Purpose:
Guidance
Publication date:
NB: November 2014
Target audience:
Health care and laboratory workers coming into contact with an infected patient or samples from
an infected patient.
Contact details:
ACDP Secretariat
Public Health England
61 Colindale Avenue
London
NW9 5EQ
[email protected]
You may re-use the text of this document (not including logos) free of charge in any format or
medium, under the terms of the Open Government Licence. To view this licence, visit
www.nationalarchives.gov.uk/doc/open-government-licence/
© Crown copyright
Published to gov.uk, in PDF format only.
www.gov.uk/dh
2
Management of Hazard
Group 4 viral haemorrhagic
fevers and similar human
infectious diseases of high
consequence
Advisory Committee on Dangerous Pathogens
This guidance was prepared by the Advisory Committee on Dangerous Pathogens (ACDP), in
conjunction with the Health and Safety Executive (HSE), with special thanks to the Health and
Safety Laboratory (HSL); the Department of Health (DH); the Devolved Administrations; and the
National Health Service (NHS).
3
Contents
EXECUTIVE SUMMARY ........................................................................................................... 5
SECTION 1: Introduction ........................................................................................................... 6
SECTION 2: Patient risk assessment ........................................................................................ 9
SECTION 3: Management of a patient categorised as ‘low possibility of VHF’ ........................ 13
SECTION 4: Management of a patient categorised as ‘high possibility of VHF’ ..................... 18
SECTION 5: Management of a patient with confirmed VHF ................................................... 23
SECTION 6: Public health actions .......................................................................................... 25
APPENDIX 1: Overview of ACDP Hazard Group 4 viral haemorrhagic fevers......................... 33
APPENDIX 2: VHF testing ....................................................................................................... 39
APPENDIX 3: Contact details for HLIU .................................................................................... 41
APPENDIX 4: Long term management of patients with confirmed VHF ................................. 42
APPENDIX 5: Transfer of a patient ......................................................................................... 51
APPENDIX 6: Specimen collection ......................................................................................... 56
APPENDIX 7: Laboratory procedures ...................................................................................... 59
APPENDIX 8: Personal protective equipment (including respiratory protective equipment) .... 63
APPENDIX 9: Management of staff accidentally exposed to potentially infectious material .... 69
APPENDIX 10: Decontamination, including treatment of laundry ............................................ 70
APPENDIX 11: Waste treatment and disposal ........................................................................ 77
APPENDIX 12: After death care .............................................................................................. 82
APPENDIX 13: Relevant health and safety legislation ............................................................. 87
APPENDIX 14: Glossary .......................................................................................................... 94
APPENDIX 15: Abbreviations .................................................................................................. 99
APPENDIX 16: Acknowledgements ....................................................................................... 101
4
EXECUTIVE SUMMARY
This document provides guidance on the risk assessment and management
of patients in the United Kingdom in whom infection with a viral haemorrhagic
fever (VHF) should be considered or is confirmed. This guidance aims to
eliminate or minimise the risk of transmission to healthcare workers and
others coming into contact with an infected patient or their samples. This
guidance replaces the previous Advisory Committee on Dangerous
Pathogens’
(ACDP)
publication
‘Management
and
Control
of
Viral
Haemorrhagic Fevers,’ published in 2012.
VHFs are severe and life-threatening viral diseases that have been reported
in parts of Africa, South America, the Middle East and Eastern Europe. VHFs
are of particular public health importance because they can spread within a
hospital setting; they have a high case-fatality rate; they are difficult to
recognise and detect rapidly; and there is no effective treatment.
Environmental conditions in the UK do not support the natural reservoirs or
vectors of any of the haemorrhagic fever viruses, and all recorded cases of
VHF in the UK have been acquired abroad, with the exception of one
laboratory worker who sustained a needlestick injury.
In preparing this guidance, ACDP undertook a new assessment of the risks
of transmission of VHF infection. Evidence from outbreaks strongly indicates
that the main routes of transmission of VHF infection are direct contact
(through broken skin or mucous membrane) with blood or body fluids, and
indirect contact with environments contaminated with splashes or droplets of
blood or body fluids. Experts agree that there is no circumstantial or
epidemiological evidence of an aerosol transmission risk from VHF patients.
Following the revised risk assessment, this guidance recommends control
options for the isolation of VHF patients in the UK. These options include
flexibility in the isolation of a patient with a VHF infection within a specialist
High Level Isolation Unit (HLIU).
5
SECTION 1: INTRODUCTION
Overview
1.
This document provides guidance on the risk assessment and
management of patients in the United Kingdom (UK) in whom infection
with a viral haemorrhagic fever (VHF) should be considered or is
confirmed.
2.
The guidance aims to eliminate or minimise the risk of transmission to
health care workers and others coming into contact with an infected
patient. In this guidance, contact is defined as exposure to an infected
person or their blood and body fluids, excretions or tissues following the
onset of their fever.
3.
VHFs are severe and life-threatening viral diseases that are endemic in
parts of Africa, South America, the Middle East and Eastern Europe.
Environmental conditions in the UK do not support the natural reservoirs
or vectors of any of the haemorrhagic fever viruses. All recorded cases
of VHF in the UK have been acquired abroad, with one exception of
a laboratory worker who sustained a needle-stick injury. There have
been no cases of person-to-person transmission of a VHF in the UK to
date of publication of this guidance.
4.
5.
VHFs are of particular public health importance because:

They can spread readily within a hospital setting;

They have a high case-fatality rate;

They are difficult to recognise and detect rapidly;

There is no effective treatment.
In preparing this guidance, ACDP undertook an assessment of the risks
of transmission of VHF infection. Evidence from outbreaks strongly
indicates that the main routes of transmission of VHF infection are direct
6
contact (through broken skin or mucous membrane) with blood or body
fluids, and indirect contact with environments contaminated with
splashes or droplets of blood or body fluids. Experts agree that there is
no circumstantial or epidemiological evidence of an aerosol transmission
risk from VHF patients.
6.
Following the revised risk assessment, this guidance recommends
control options for the isolation of VHF patients in the UK. These options
include flexibility in the isolation of a patient with a VHF infection within a
specialist High Level Isolation Unit (HLIU).
7.
This guidance only covers those VHFs that are caused by pathogens
classified as ACDP Hazard Group 4. Further information about the range
of ACDP Hazard Group 4 viruses that cause viral haemorrhagic fever is
included in Appendix 1.
8.
The guidance also applies to cases of similar infectious diseases,
including new or emerging infections, which have a significant health
impact and may present a serious risk to public health in the UK.
7
The ACDP Hazard Group 4 viral haemorrhagic fever viruses
ARENAVIRIDAE
BUNYAVIRIDAE
Old World arenaviruses
Nairoviruses
Lassa
Crimean Congo haemorrhagic
Lujo
fever
New World arenaviruses
Chapare
Guanarito
Junín
Machupo
Sabiá
FLAVIVIRIDAE
FILOVIRIDAE
Kyasanur forest disease
Ebola
Alkhurma haemorrhagic fever*
Marburg
Omsk haemorrhagic fever
*
Hazard Group 3 agent, but included in this guidance as “similar human
infectious disease of high consequence”
Intended users of this guidance
9.
This guidance is for:

healthcare staff in emergency departments, infectious disease
departments, infection control, microbiology/virology, acute
medical units;

ambulance staff, who may be required to transport a patient in
whom VHF is suspected or confirmed;

those working in laboratories dealing with specimens from
patients in whom VHF is suspected or confirmed;

public health professionals, including those in Port Health
Authorities, who may be required to carry out public health
actions associated with a VHF case;

mortuary and funeral personnel, who may need to deal with a
VHF case.
8
SECTION 2: PATIENT RISK ASSESSMENT
Risk assessment

Risk assessment is a legal obligation;

Know who is your lead for risk assessment and be familiar with local risk
assessment arrangements;

Use the risk assessment algorithm on page 12 to determine whether a
febrile patient with a travel or exposure history within 21 days may have a
VHF infection;

The patient’s risk assessment determines the level of staff protection and
the management of the patient;

The risk to staff may change over time, depending on the patient’s
symptoms, the results of diagnostic tests and/or information from other
sources. Patients with a VHF can deteriorate rapidly.
Why is a risk assessment necessary?
1.
The Control of Substances Hazardous to Health (CoSHH) Regulations
requires employers to assess risk to their employees in the workplace.
This includes making an assessment of the risk of acquiring a VHF
infection in a healthcare setting or other workplace. The purpose of risk
assessment is to enable decisions to be made about the actions needed
to control the risk and prevent spread of infection. Risk assessment
therefore embraces both assessment of the patient for the possibility of
VHF and assessment of associated risks to staff. Measures to control
any risks include implementation of practical infection control measures,
information provision, training and health surveillance where the
assessment shows that these are required.
2.
In the UK, only persons who have; (i) travelled to an area where VHFs
occur; and/or (ii) been exposed to a patient or animal infected with VHF
9
(including their blood, body fluids or tissues); or (iii) worked in a
laboratory with the infectious agents of VHFs; are at risk of infection from
VHFs.
How to conduct the patient risk assessment
3.
The patient risk assessment should be led by a senior member of the
medical team responsible for the acute care of patients, for example the
emergency care physician, emergency department consultant or
admitting team consultant. The consultant microbiologist/virologist may
also need to be involved.
4.
For any patient who has had a fever [≥37.5°C] or history of fever in the
previous 24 hours and a travel history or epidemiological exposure within
21 days, follow the major steps in the pathway from identification to
diagnosis in the patient risk assessment algorithm (page 12). This will
establish the patient’s VHF risk category, which determines the
subsequent management of the patient and the level of protection for
staff. Further information is provided in the subsequent sections of this
guidance.
5.
Initiating the patient risk assessment algorithm should become normal
practice in emergency departments or Acute Medical Units for any
patient who has a fever [≥37.5°C] or history of fever in the previous 24
hours and a relevant travel history or epidemiological exposure within 21
days.
6.
The algorithm deals with the management of the patient, diagnostic
testing and the level of staff protection, all of which are dependent on the
possibility of VHF infection and the patient’s symptoms.
10
7.
Standard precautions and good infection control are paramount to
ensure staff are not put at risk whilst the initial risk assessment is carried
out. It is assumed throughout this guidance that staff will be
following standard precautions. If these measures are not already in
place, they must be introduced immediately when dealing with a patient
in whom VHF is being considered.
8.
The patient’s VHF risk category can change depending on the patient’s
symptoms and/or the results of diagnostic tests. It is important to note
that a patient with a VHF infection can deteriorate rapidly.
The patient’s VHF risk category
9.
The additional questions in the algorithm are designed to thoroughly
assess the risk of VHF infection. Following the additional questions, the
patient will be categorised as one of the following:

Unlikely to have a VHF (see below);

Low possibility of VHF (see Section 3);

High possibility of VHF (see Section 4);

Confirmed VHF (see Section 5).
10. Summary information on VHFs is available in Appendix 1, and detailed
information on geographic distribution is provided in the VHF risk maps
on the PHE and WHO websites.
11. Information on recent VHF outbreaks can be accessed on travel health
websites such as Travax and NaTHNaC, the PHE website and via global
disease updates on ProMed and WHO.
11
Patients who are unlikely to have a VHF infection
Patients with a fever ≥37.5°C are highly unlikely to have a VHF infection
if:

They have not visited a VHF endemic area within 21 days of becoming ill;

They have not become unwell within 21 days of caring for or coming into
contact with the bodily fluids of / handling clinical specimens from a live or
dead individual or animal known or strongly suspected to have a VHF;

If their UK malaria screen is negative and they are subsequently afebrile for
>24 hours;

If their UK malaria screen is positive and they respond appropriately to
malaria treatment;

If they have a confirmed alternative diagnosis and are responding
appropriately.
12. The risk of VHF in the patient should be reassessed if a patient with a relevant
exposure history fails to improve or develops one of the following:

Nosebleed;

Bloody diarrhoea;

Sudden rise in aspartate transaminase (AST);

Sudden fall in platelets;

Clinical shock;

Rapidly increasing O2 requirements in the absence of other diagnosis
12
VIRAL HAEMORRHAGIC FEVERS RISK ASSESSMENT (Version 5: 06.11.2014)
VHF ENDEMIC COUNTRIES:
Information on VHF endemic countries can be found at https://www.gov.uk/viral-haemorrhagic-fevers-origins-reservoirs-transmission-and-guidelines
or see VHF in Africa map at https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/365845/VHF_Africa_960_640.png
ADDITIONAL QUESTIONS:
-Has the patient travelled to any area where there is a current VHF outbreak? (http://www.who.int/csr/don/en/ and http://www.promedmail.org/) OR
-Has the patient lived or worked in basic rural conditions in an area where Lassa Fever is endemic? (https://www.gov.uk/lassa-fever-origins-reservoirs-transmission-and-guidelines) OR
-Has the patient visited caves / mines, or had contact with or eaten primates, antelopes or bats in a Marburg / Ebola endemic area? (https://www.gov.uk/ebola-and-marburghaemorrhagic-fevers-outbreaks-and-case-locations) OR
-Has the patient travelled in an area where Crimean-Congo Haemorrhagic Fever is endemic (http://www.who.int/csr/disease/crimean_congoHF/Global_CCHFRisk_20080918.png?ua=1)
AND sustained a tick bite* or crushed a tick with their bare hands OR had close involvement with animal slaughter? (*If an obvious alternative diagnosis has been made e.g. tick typhus,
then manage locally)
START
Does the
patient have a
o
fever (≥37.5 C) OR
history of fever in
past 24
hours?
Has
the patient
developed symptoms
within 21 days of leaving a VHF
endemic country? (See above
info box for data
on VHF endemic
countries)
YES
Has
the patient
cared for/come into
contact with body fluids
of/handled clinical specimens
(blood, urine, faeces, tissues,
laboratory cultures) from an individual
or laboratory animal known or
strongly suspected to
have VHF within the
past 21 days?
NO
YES
NO
Malaria
test
POSITIVE?
NO
HIGH POSSIBILITY OF VHF
-ISOLATE PATIENT IN A SIDE ROOM
-Urgent Malaria investigation
-Full blood count, U&Es, LFTs, Clotting screen,
CRP, glucose, blood cultures
-Inform laboratory of possible VHF case (for
specimen waste disposal purposes if confirmed)
YES
YES
NO
LOW POSSIBILITY OF VHF
-Urgent Malaria investigation
-Urgent local investigations as
normally appropriate, including
blood cultures
Does the
patient have
extensive bruising
or active
bleeding?
Has the
patient returned
from a VHF epidemic
country (Ebola: Sierra
Leone, Guinea,
Liberia or
Mali?
NO
Manage as Malaria;
VHF unlikely
Malaria
test
POSITIVE?
YES
NO
YES
YES
VHF Unlikely;
manage locally
YES
Yes to any
additional question?
(See above box)
VHF Unlikely;
manage locally
NO
Manage as malaria, but
consider possibility of dual
infection with VHF
-Discuss with Infection Consultant
(Infectious Disease/Microbiology/Virology)
-Infection Consultant to discuss VHF screen
with Imported Fever Service (0844 7788990)
-Notify Local Health Protection Unit
-Consider empiric antimicrobials
NO
Alternative
diagnosis
confirmed?
Clinical
concern OR
continuing fever
after 72
hours?
NO
YES
-Possibility of VHF; Discuss with Infection
Consultant (Infectious
Disease/Microbiology/Virology)
-Infection Consultant to consider
discussion of VHF screen with Imported
Fever Service (0844 7788990)
Is the
patient fit for
outpatient
management?
YES
VHF Unlikely;
manage locally
NO
MINIMAL RISK
Standard precautions apply:
Hand hygiene, gloves, plastic apron
(Eye protection and fluid repellent surgical facemask for splash
inducing procedures)
STAFF AT RISK
Hand hygiene, double gloves, fluid repellent disposable coverall or
gown, full length plastic apron over coverall/gown, head cover
e.g. surgical cap, fluid repellent footwear e.g. surgical boots, full
face shield or goggles, fluid repellent FFP3 respirator
NO
YES
YES
NO
INFECTION CONTROL PERSONAL PROTECTION MEASURES:
Does the
patient have
extensive bruising or
active bleeding or
uncontrolled diarrhoea
or uncontrolled
vomiting?
-Inform/update Local Health Protection Unit
-Ensure patient contact details recorded
-Patient self-isolation
-Follow up VHF screen result
-Review daily
Admit
VHF test
POSITIVE?
NO
CONFIRMED VHF
-Contact High Level Isolation Unit for transfer
(020 7794 0500: Royal Free)
-Launch full public health actions, including
categorisation and management of contacts
-Inform lab if other lab tests are needed
13
YES
VHF Unlikely;
manage locally
SECTION 3: MANAGEMENT OF A PATIENT
CATEGORISED AS ‘LOW POSSIBILITY OF VHF’
NOTE: It is recommended that, if a patient has extensive bruising or active
bleeding, the lead clinician should manage the patient as “high possibility of
VHF”; see Section 4.
Patient categorised as ‘low possibility of VHF’

A senior member of the medical team who is responsible for the acute
care of the patient should be the lead clinician;

Infection control measures appropriate to the patient’s risk category and
clinical care procedures should be put in place;

Instigate urgent malaria screen and local diagnostic investigations as
normal;

If an inpatient who is malaria negative has a continuing fever and relevant
travel history, without diagnosis, discuss with Infection Consultant
(ID/Microbiology/Virology) with a view to arranging VHF screen.
Infection control measures
1.
A febrile patient categorised as ‘Low possibility of VHF’ should be
isolated in a single side room to limit contact until the possibility of
transmissible infection has been ruled out. The side room should have
dedicated en-suite facilities or at least a dedicated commode.
2.
It is assumed that all staff will already be using standard precautions
(hand hygiene, gloves plastic apron) as appropriate. If not, these must be
immediately introduced.
14
Infection control measures for ‘low possibility of VHF’
Staff protection
Control measures

Hand hygiene

Gloves

Plastic apron

Fluid repellent surgical facemask
inducing procedures

Eye protection
Additional protection for potential

FFP3 respirator or EN certified
Standard precautions
Additional
aerosol
protection
generating
for
splash
equivalent
procedures

based on risk assessment for other
Eye protection
infections known to be transmitted
by aerosol.
3.
4.
Potential aerosol generating procedures include:

Endotracheal intubation;

Bronchoscopy;

Airway suctioning;

Positive pressure ventilation via face mask;

High frequency oscillatory ventilation;

Central line insertion;

Diagnostic sputum induction.
Appendix 8 gives information on personal protective equipment including
respiratory protection.
15
5.
Single use (disposable) equipment and supplies should be used. The
use of a needle-free intravenous system to eliminate the risk of
needlestick injuries should also be considered.
Diagnostic investigations
6.
All samples from patients in the ‘low possibility of VHF’ category can be
treated as standard samples. Investigations required will include
URGENT Malaria investigations. Other investigations, as locally
appropriate, may include full blood count, urea and electrolytes (U&Es),
liver function tests (LFTs), glucose, C-reactive proteins (CRP),
coagulation studies, urine, stool and blood cultures, and chest x-ray
(CXR). However, if the patient has extensive bruising or active bleeding,
they should be regarded as “high possibility of VHF” and discussed with
an Infection Consultant (ID/Microbiology/Virology).
7.
Malaria remains the most likely diagnosis and therefore screening for
malaria is most urgent even if the patient has already had a malaria
screen performed with a negative result.
8.
Testing of specimens for patient management should be performed
using containment level 2 (CL2) laboratory procedures. Appendix 6
provides guidance on collecting and handling specimens from a patient
categorised as ‘low possibility of VHF’.
Diagnostic test results and subsequent patient management
Malaria investigation results
9.
If the malaria result is positive, treatment for malaria should begin
immediately. Up-to-date UK malaria treatment guidelines (published in
the Journal of Infection in 2007) are available on the PHE website. The
patient may be re-categorised as ‘VHF unlikely’ if they are responding to
16
malaria treatment; however, patients who fail to respond appropriately to
antimalarial therapy, particularly if there is the development of further
features suggestive of VHF, should be re-evaluated for the possibility of
VHF and investigated accordingly. See Section 2 for information on the
management of patients categorised as ‘VHF unlikely’.
10. If the malaria test is negative, but an alternative diagnosis has been
made and/or the patient becomes apyrexial, then the patient can be
managed locally.
11. If the malaria result is negative, the patient remains pyrexial (≥37.5°C)
and no diagnosis has been made, the case should be discussed with a
local Infection Consultant (ID/Microbiology/Virology). The Infection
Consultant should consider discussion of VHF screening with Imported
Fever Service (0844 7788990). See Appendix 2 for details of VHF
screening process.
17
SECTION 4: MANAGEMENT OF A PATIENT
CATEGORISED AS ‘HIGH POSSIBILITY OF VHF’
Patient categorised as ‘high possibility of VHF’

The lead clinician who is responsible for the acute care of the patient should
be a senior member of the medical team;

The patient should be isolated in a single side room immediately;

Enhanced infection control measures appropriate to the patient’s symptoms
and clinical care procedures should be put in place;

Carry out an urgent malaria screen, and local diagnostic investigations as
appropriate (see Appendix 7);

If
malaria
test
is
negative,
discuss
with
Infection
Consultant
(ID/Microbiology/Virology). Infection Consultant to arrange VHF screen with
Imported Fever Service (IFS)

Contact Local Health Protection Unit

If the patient’s VHF screen is positive, contact the HLIU (Appendix 3) and
launch full public health actions.

If malaria test is positive and the patient has returned from a country affected
by the current ebola outbreak, then dual infection should be considered and
discuss with infection consultant (infectious disease/microbiology/virology).
Infection control measures
1.
The patient should be isolated in a single side room immediately to limit
contact. The side room should have dedicated en-suite facilities or at
least a dedicated commode.
2.
The number of staff in contact with the patient should be restricted.
18
3.
The level of staff protection required is dependent on the patient’s
symptoms and is set out in the table below:
Infection control measures for ‘high possibility of VHF’
Staff protection
Control measures
Standard precautions plus droplet

Hand hygiene
precautions

Double gloves

Fluid
repellent
disposable
coverall or gown

Full length plastic apron over
coverall/gown

Head cover e.g. surgical cap

Fluid
repellent
footwear
e.g.
surgical boots/shoe covers

Full face shield or goggles

Fluid repellent FFP3 respirator
used as splash protection. If the
respirator is to be used as
respiratory
protection
managing
a
infections
known
when
patient
to
with
be
transmitted by aerosol, it must
be worn as per manufacturer’s
recommendations (see Appendix
8)
4.
Appendix 8 gives further information on personal protective equipment
including respiratory protection.
19
5.
It is recommended that, if a patient is bruised or bleeding or has
uncontrolled diarrhoea or uncontrolled vomiting, the lead clinician should
ensure that VHF testing is carried out and have an urgent discussion
with HLIU concerning patient management and possible early transfer to
the HLIU.
See Appendix 3 for contact details and Appendix 5 for
transport information.
6.
Single use (disposable) equipment and supplies should be used. The
use of a needle-free intravenous system to eliminate the risk of
needlestick injuries should also be considered.
7.
Guidance on waste, laundry, decontamination and disinfection is
provided in Appendices 10 and 11.
8.
Communication with staff about potential infection risks is paramount.
Staff must be informed about and understand the risks associated with a
VHF patient, for example:

The severity of a VHF if infection is confirmed;

That virus may be present:
o in blood;
o in body fluids, including urine;
o on contaminated instruments and equipment;
o in waste;
o on contaminated clothing;
o on contaminated surfaces.

That exposure to virus may occur:
o directly, through exposure (broken skin or mucous
membranes) to blood and/or body fluids during invasive,
aerosolising or splash procedures;
o indirectly, through exposure (broken skin or mucous
membranes) to environments, surfaces, equipment or
20
clothing contaminated with splashes or droplets of blood
or body fluids.
Diagnostic investigations
9.
Investigations required will include URGENT malaria tests as well as full
blood count, U&Es, LFTs, clotting screen, CRP, glucose and blood
cultures. These tests should be performed using CL2 laboratory
procedures (Appendix 7). Analysis of specimens should not be delayed
whilst awaiting the results of VHF screens. Appendix 6 provides
guidance on collecting specimens from a patient categorised as ‘high
possibility of VHF’.
10. Malaria remains the most likely diagnosis and therefore screening for
malaria is urgent regardless of a previous negative malaria screen
performed elsewhere.
11. For waste disposal purposes, the laboratory should be informed that
specimens are to be retained until VHF status is known.
12. If the malaria screen is negative and VHF is still suspected clinically, the
case should be discussed promptly with the local Infection Consultant
(ID/Microbiology/Virology). The Infection Consultant should contact the
Imported Fever Service (0844 7788990) to arrange an urgent VHF
screen (See Appendix 2). The Local Health Protection Unit should also
be informed at this stage.
13. If the malaria screen is positive and the patient has returned from a
country affected by the current Ebola outbreak, then dual infection
should be considered and discuss with infection consultant (infectious
disease/microbiology/virology).
21
VHF screen results and subsequent patient management
14. If the VHF screen is positive, a number of urgent actions are
required – see Section 5 for details.
15. If the VHF screen is negative, then VHF is unlikely. Patient can be
managed locally. If there is further clinical concern the patient should be
discussed with Imported Fever Service.
22
SECTION 5: MANAGEMENT OF A PATIENT WITH
CONFIRMED VHF
Patient with confirmed VHF A patient who has had a positive VHF screen result
should be managed in an HLIU, unless exceptional circumstances prevent transfer
of the patient;

Full public health actions should be launched;

Once the patient has been transferred, testing of specimens should be
carried out in the dedicated laboratory at the HLIU.
1.
If a patient has a confirmed VHF, the following urgent actions are
required:

Restrict the number of staff in contact with the patient and
compile a list of all staff who have been in direct contact with the
patient;

Enhance levels of personal protection for those in direct contact
with the patient:
o Hand hygiene;
o Double gloves;
o Fluid repellent disposable coverall or gown;
o Full length plastic apron over coverall/gown;
o Head cover e.g. surgical cap;
o Fluid repellent footwear e.g. surgical boots/shoe covers;
o Full face shield or goggles;
o Fluid repellent FFP3 respirator used as splash protection.

If the respirator is to be used as respiratory protection when
managing a patient with infections known to be transmitted by
aerosol,
it
must
be
worn
recommendations (see Appendix 8).
23
as
per
manufacturer’s

Lead clinician should discuss urgently with the HLIU to arrange
for the immediate transfer (see Appendix 3 for contact details,
Appendix 5 for transfer information).

Notify the infection control team of the positive VHF screen
result;

Launch full public health actions (see Section 6), including
formation of an Incident Control Team.
2.
If, after discussion with the HLIU, it is judged that the condition of the
patient precludes transfer to the HLIU, an immediate discussion with the
Lead for Infection Control should take place regarding local risk
assessment and control measures. Discussions with the Health and
Safety Executive and experts at the HLIU are also necessary. Advice on
managing a VHF positive patient in a non-HLIU environment is provided
in Appendix 4.
3.
Prior to transfer or if the patient is unable to be transferred, testing of
specimens should be carried out in accordance with Appendix 7.
24
SECTION 6: PUBLIC HEALTH ACTIONS
Public health actions must be launched if the VHF screen result is positive.

Inform Local Health Protection Team

Formation of an Incident Control Team;

Notification of the case by the reference laboratory to the relevant
regulatory health body;

Notification of the case by PHE to the European Centre for Disease
Control (ECDC) and the World Health Organisation (WHO);
1.

Categorisation and management of contacts; and

Determine media handling strategy.
In England, VHF is a notifiable disease under Schedule 1 of the Health
Protection (Notifications) Regulations 2010, and notification of VHFs is
classified as urgent. The registered medical practitioner (RMP) attending
the patient must therefore notify the highly possible case by telephone to
the proper officer of the local authority in which the patient currently
resides, within 24 hours. The oral notification should be followed up with
a written notification within three days.
2.
In Wales, VHF is a notifiable disease under Schedule 1 of the Health
Protection (Notifications, Wales) Regulations 2010, and notification of
VHFs is classified as urgent. The RMP must notify the highly possible
case to the proper officer, who is the Consultant in Communicable
Disease Control of the health protection team of the Public Health Wales
NHS Trust, by telephone as soon as reasonably practicable.
3.
In Scotland, VHF is a notifiable disease under Schedule 1, Part 1
(Notifiable Diseases) of the Public Health etc. (Scotland) Act 2008. The
25
RMP must notify the suspected case to the relevant health board, by
telephone as soon as possible.
4.
In Northern Ireland, VHF is a notifiable disease under Schedule 1 of the
Public Health Act (Northern Ireland) 1967. The RMP must notify the
suspected case to the Regional Director of Public Health of the Public
Health Agency by telephone as soon as reasonably practicable.
5.
In all countries, the RMP should not wait for laboratory confirmation or
results of other investigations in order to notify a suspect case. If
laboratory test results refute the clinical diagnosis later, the RMP is not
required to de-notify the case.
Forward notification of the suspected case
6.
In England and Wales, the proper officer must disclose the content of
notification received from the RMP to the following, by telephone, within
24 hours:

Public Health England (PHE) or the Public Health Wales NHS
Trust (in Wales) – however, if the proper officer of the local
authority is an employee of these institutions, then notification by
the proper officer to the institution will be automatically effected;

the proper officer of the local authority in which the patient
usually resides, if different; and

the proper officer of the port health authority or the local
authority in which the port is located, if the patient has
disembarked from a ship, hovercraft, aircraft or international
train, and this fact is known to the proper officer of the local
authority who receives the notification;

the local Director of Public Health;

the Department of Health;

the Welsh Government.
26
7.
In Scotland, the NHS Board health protection team must notify Health
Protection Scotland and the Chief Medical Officer’s team in the Scottish
Government.
8.
In Northern Ireland, there are no forward notifications dictated by law.
9.
For the UK, patients being repatriated by air ambulance, the notification
requirements of the Public Health (Aircraft) Regulations 1979 as
amended 2007 will apply.
Identification of contacts
10. It is a public health responsibility:

To identify, assess, and categorise contacts of a patient with VHF;

To ensure the appropriate monitoring of higher risk contacts;

To arrange further evaluation for contacts who develop a
temperature of ≥37.5ºC within 21 days of the last possible
exposure;

To consider antiviral prophylaxis, and arrange as necessary.
11. A contact is defined as a person who has been exposed to an infected
person or their blood and body fluids, excretions or tissues following the
onset of their fever. This may include contacts that are not in the UK. For
management of staff accidentally exposed see Appendix 9.
12. As soon as a patient has been categorised as confirmed VHF all those
who have had contact with the patient should be identified as far as
possible.
13. For guidance on risks to contacts on aircraft see European RAGIDA
guidance at
http://ecdc.europa.eu/en/publications/Publications/1012_GUI_RAGIDA_2.pdf.
27
Formation and role of an Incident Control Team
14. An Incident Control Team (ICT) will need to be convened and should
include representatives from all involved parties, including the local
public health body and the hospital Trust. The lead for this will depend on
the particular situation.
15. The ICT will also need to:

inform PHE, as the UK competent body, that the VHF screen
result was positive;

determine who is responsible for the assessment, categorisation
and management of contacts, including those outside the UK,
the actions to be taken and the advice to be given;

determine who is responsible for media handling;

agree all key media messages between all parties.
Notification of the case by the laboratory
16. The VHF screen will be carried out by a PHE reference laboratory (see
Appendix 2 for contact details). Diagnostic evidence of VHF infection
must be urgently notified by the PHE reference laboratory to the
relevant public health body, even if the case has already been notified
by the RMP. If the case is:

in England, this notification is to the PHE;

in Wales, this notification is to the Consultant in Communicable
Disease Control of the health protection team of the Public
Health Wales NHS Trust;

in Scotland, this notification is to the local NHS Board health
protection team;

in Northern Ireland, this notification is to the Public Health
Agency.
28
17. Notification of the case to European Centre for Disease Control (ECDC)
and World Health Organisation WHO
18. On receipt of confirmation that the VHF screen result was positive, the
PHE, as the UK competent body, will notify the ECDC via the early
response and warning system (EWRS) and the WHO under the
International Health Regulations (IHR), of the case.
Assessment, categorisation and management of contacts
19. The ICT will determine who is/are responsible for the assessment,
categorisation and management of contacts, and designate a Monitoring
Officer to monitor the higher risk contacts and the follow up actions to be
taken.
20. Each potential contact should be individually assessed for risk of
exposure and categorised according to categories listed in the table
below:
29
Categorisation of contacts
Risk category
Description
No risk (Category 1)
fluids.
No direct contact with the patient or body
Casual contact, e.g. sharing a room with
the patient, without direct contact with
body fluids or other potentially infectious
material.
Low risk (Category 2)
Direct contact with the patient, e.g. routine
medical/nursing care, handling of
clinical/laboratory specimens, or handled
body fluids, and wore personal protective
equipment appropriately.
High risk (Category 3)
Unprotected exposure of skin or mucous
membranes to potentially infectious blood
or body fluids, including on clothing and
bedding.
This includes:




unprotected handling of
clinical/laboratory specimens;
mucosal exposure to splashes;
needlestick injury;
kissing and/or sexual contact.
21. Contacts should be managed as outlined in the table below. Sample
information sheets (general, category 1, category 2 and category 3) are
available from the PHE Duty Doctor (via 020 8200 6868). Information
sheets should include contact details for the Monitoring Officer.
22. There should be no restrictions on work or movement for any contacts,
unless disease compatible symptoms develop.
30
Management of contacts
Risk category
Action and Advice
No risk (Category 1)
Reassure about absence of risk;
Provide category 1 factsheet;
Low risk (Category 2)
Reassure about low risk;
Passive monitoring
Self-monitor for fever and other disease
compatible symptoms for 21 days from
last possible exposure; Report to the
Monitoring Officer if temperature ≥37.5ºC,
with further evaluation as necessary;
Provide category 2 factsheet;
High risk (Category 3)
Inform about risks;
Active monitoring
Record own temperature daily for 21 days
following last contact with the patient and
report this temperature to the Monitoring
Officer by 12 noon each day, with further
evaluation as necessary; Inform
Monitoring Officer urgently if symptoms
develop; Provide category 3 factsheet.
23. Antivirals, specifically ribavirin, have been shown to be effective in the
treatment of early-stage arenavirus infections, particularly Lassa fever.
There is however evidence to suggest that ribavirin may prolong the
incubation period for Lassa fever. Antivirals are not generally
recommended for contacts due to the absence of evidence of their
proven effectiveness for prophylaxis. However, antivirals may be
31
considered for those direct contacts at highest risk, subject to individual
risk assessment.
Media handling
24. A member of the ICT should be made responsible for media handling. It
may be necessary to appoint a spokesperson if there is significant media
attention.
25. There should be no release of information to, or discussions with, the
media without the agreement of all parties. All media statements and
messages will need to be agreed by all parties. Media statements and
messages should also be shared with the relevant UK Health
Department.
32
APPENDIX 1: OVERVIEW OF ACDP HAZARD GROUP 4
VIRAL HAEMORRHAGIC FEVERS
1.
Viral haemorrhagic fever is a term used to describe a severe, multiorgan disease in which the overall vascular system is damaged and the
body’s ability to regulate itself is impaired. Disease is often accompanied
by varying degrees of haemorrhage which can add greatly to the
difficulties of patient management and be life-threatening for the patient.
2.
Several viruses from the arenavirus, filovirus, bunyavirus and flavivirus
families are known to cause haemorrhagic fevers. They are zoonotic or
arboviral infections and dependent on an animal or insect host for
transmission. The viruses are geographically restricted to the areas of
their host species.
3.
Humans are not the natural reservoirs of any of these viruses, but can
become infected when they come into contact with infected hosts. In
addition, many of these viruses are capable of person-to-person
transmission, usually via direct contact with infected blood or body fluids,
or indirectly via contact with environments contaminated with splashes or
droplets of blood or body fluids.
4.
This guidance covers those VHFs that are classified as Hazard Group 4
pathogens. Other diseases with haemorrhagic manifestations such as
dengue, yellow fever, leptospirosis, Rift Valley fever, and hantaviruses
are not covered by this guidance.
5.
The following table summarises Hazard Group 4 haemorrhagic fever
viruses, their diseases, geographies and transmission routes.
33
Virus
Disease
Geographical
distribution
Transmission
routes/vectors
Further information
West and Central Africa
In particular: Guinea,
Liberia, Sierra Leone,
Nigeria
Contact with excreta, or
materials contaminated with
excreta, of infected
multimammate rat
(Mastomys spp).
https://www.gov.uk/lassa-feverorigins-reservoirs-transmissionand-guidelines
Also consider: Central
African Republic, Mali,
Senegal, Burkina Faso,
Cote D’Ivoire, Ghana,
Gabon, Uganda
Inhalation of aerosols of
excreta of multimammate
rat.
ARENAVIRIDAE
Old World arenaviruses
Lassa
Lujo
Lassa fever
Unnamed
Southern Africa
One outbreak to date (5
cases) in South Africa,
ex-Zambia
Contact with blood or body
fluids from infected
patients, or sexual contact.
Transmission to the index
case unknown.
Direct contact with infected
patient, blood or body
fluids.
First identified in October 2008
following a nosocomial outbreak in
South Africa involving five people,
four of whom died.
34
Virus
Disease
Geographical
distribution
Transmission
routes/vectors
Further information
Direct contact (e.g. bite)
with infected rat or mouse.
http://www.cfsph.iastate.edu/Facts
heets/pdfs/viral_hemorrhagic_fever
_arenavirus.pdf
New World arenaviruses (Tacaribe complex)
Chapare
Chapare
haemorrhagic
fever
Bolivia
Guanarito
Venezuelan
haemorrhagic
fever
Central Venezuela
Junín
Argentine
haemorrhagic
fever
Argentina
Bolivian
haemorrhagic
fever
North eastern Bolivia
Beni department
Machupo and Guanarito
only:
Brazilian
haemorrhagic
fever
Brazil
Contact with blood or body
fluids from infected
patients.
Machupo
Sabiá
One outbreak to date in
Cochabamba, Bolivia
Pampas region
One case to date
Direct contact with excreta
of infected rat or mouse.
Contact with materials (e.g.
food) contaminated with
excreta from infected rat or
mouse.
Inhalation of aerosols of
excreta (often in dust) of rat
or mouse.
35
Virus
Disease
Geographical
distribution
Transmission
routes/vectors
Further information
Bite of an infected tick
(most commonly Hyalomma
ticks).
https://www.gov.uk/crimean-congohaemorrhagic-fever-originsreservoirs-transmission-andguidelines
BUNYAVIRIDAE
Nairoviruses
Crimean Congo
haemorrhagic
fever
Crimean
Congo
haemorrhagic
fever
Central and Eastern
Europe, Central Asia, the
Middle East, East and
West Africa.
Recent outbreaks in
Russia, Turkey, Iran,
Kazakhstan, Mauritania,
Kosovo, Albania, Pakistan
and South Africa
Contact with infected
patients, their blood or
body fluids.
Contact with blood or
tissues from infected
livestock.
36
Virus
Disease
Geographical
distribution
Transmission
routes/vectors
Further information
Transmission to the index
case probably via contact
with infected animals.
https://www.gov.uk/government/col
lections/ebola-virus-diseaseclinical-management-and-guidance
FILOVIRIDAE
Ebola
-
-
Ebola
Western, Central and
Ebola Zaïre haemorrhagic Eastern Africa
fever
Outbreaks have occurred
Ebola Sudan
in the Democratic Republic
Ebola Tai
of the Congo, Sudan,
Forest
Uganda, Gabon, Republic
(formerly
of Congo,Côte D’Ivoire,
Côte
Sierra Leone, Guinea,
d’Ivoire)
Nigeria and Liberia
Ebola
Bundibugyo
Contact with infected blood
or body fluids.
https://www.gov.uk/ebola-andmarburg-haemorrhagic-feversoutbreaks-and-case-locations
- Ebola
Reston and
Siena
Marburg
Marburg
Central and Eastern
haemorrhagic Africa
fever
Outbreaks have occurred
in Angola, the Democratic
Republic of Congo, Kenya,
Uganda and South Africa
(ex-Zimbabwe)
Transmission to the index
case probably via contact
with infected animals
(?fruit bats).
https://www.gov.uk/marburg-virusdisease-origins-reservoirstransmission-and-guidelines
Contact with infected blood
or body fluids.
https://www.gov.uk/ebola-andmarburg-haemorrhagic-feversoutbreaks-and-case-locations
37
Virus
Disease
Geographical
distribution
Transmission
routes/vectors
Further information
Kyasanur
forest disease
India
Bite of an infected tick,
most commonly
Haemaphysalis spinigera.
Common in young adults exposed
in the forests of western Karnataka
– approximately 100-500 cases per
year. Case fatality rate is estimated
at 2-10%.
FLAVIVIRIDAE
Kyasanur forest
disease
Western districts of
Karnataka state
Contact with an infected
animal, most commonly
monkeys or rodents.
Alkhurma (Al
Khumrah)
haemorrhagic
fever (See info
box in Section
1)
Alkhurma
haemorrhagic
fever
Saudi Arabia
Omsk
haemorrhagic
fever
Omsk
haemorrhagic
fever
Russian Federation
Makkah (Mecca),
Jeddah, Jizan, Najran
regions
Novosibirsk region of
Siberia
Contact with an infected
animal (sheep, camels).
Bite of an infected tick or
mosquito (principal vector
species not yet identified).
Bite of an infected tick,
most commonly
Dermacentor reticulatus.
Person-to-person
Cases have been reported outside
Saudi Arabia, but have had contact
with animals that likely originated
in Saudi Arabia e.g. case in an
Italian tourist in 2010 who visited a
camel market in southern Egypt.
Virus circulates in muskrats, and
other animals, in the forest Steppe
regions of Russia. Infection most
common in farmers and their
families.
38
APPENDIX 2: VHF TESTING
Imported Fever Service
1.
To discuss a case and/or arrange VHF screening, telephone 0844
7788990 (24 hour). In the event that this number is unobtainable, the
duty Consultant for the Rare and Imported Pathogens Laboratory can be
contacted via the PHE Porton switchboard number provided below.
https://www.gov.uk/imported-fever-service-ifs
VHF Screening
2.
If the malaria result is negative, the patient remains pyrexial (≥37.5°C)
and no diagnosis has been made, the case should be discussed with a
local Infection Consultant (ID/Microbiology/Virology). The Infection
Consultant should consider discussion of VHF screening with Imported
Fever Service (0844 7788990). The IFS doctor will require full details of
the patient's travel history, possible exposure activities, clinical
presentation, investigation results and clinical management to date. The
differential diagnosis, the appropriate samples to send (usually EDTA
and
clotted
blood
+/-
urine),
the
necessary sample
transport
arrangements and anticipated test turnaround times will be discussed.
3.
Note that if a VHF screen is being considered, the Infection Consultant
must contact the Imported Fever Service prior to sending any samples.
Samples will usually be directed to the Rare and Imported Pathogens
Laboratory (RIPL) at PHE Porton at the address provided in Appendix 3.
Results are usually available within 6-8 hours following receipt of the
specimen. In the meantime, diagnostic investigations and local
management should continue. RIPL will normally test in parallel for other
agents likely to cause similar presentations that occur in the country of
origin e.g. dengue, rickettsial infections, leptospirosis.
39
VHF screen results
4.
If the VHF screen is positive, a number of urgent actions are required
– see Section 5 for details.
5.
If the VHF screen is negative, the possibility of the patient having a
VHF infection should be maintained until an alternative diagnosis is
confirmed or the patient has been afebrile for 24 hours. The patient
should therefore remain isolated in a single side room, and the infection
control measures, including staff protection, as outlined in this Section
should be maintained until an alternative diagnosis is confirmed or the
patient recovers.
Reference laboratories – for VHF screen
6.
Rare and Imported Pathogens Laboratory (RIPL)
PHE Porton
Porton Down
Salisbury Wiltshire
SP4 0JG
Tel: 01980 612100 (24 hour)
7.
The Imported Fever Service will usually direct the referring laboratory to
send samples to RIPL as above. In unusual circumstances, where the
RIPL lab is not available, samples may be directed to Colindale at the
address below.
Microbiology Services Division – Colindale
61 Colindale Avenue
Colindale
London
NW9 5HT
Tel: 0208 200 4400 or 0208 200 6868 (24 hour)
40
APPENDIX 3: CONTACT DETAILS FOR HLIU
High Level Isolation Units
1.
Royal Free London NHS Foundation Trust, London
Telephone (24 hours, ask for infectious disease consultant on call) 020
7794 0500 or 0844 8480700 (local rate number when calling from
outside London)
www.royalfree.nhs.uk
2.
The HLIU at Newcastle upon Tyne NHS Foundation Trust is currently
closed at the time of publication.
41
APPENDIX 4: PRINCIPLES FOR THE ISOLATION OF
PATIENTS WITH CONFIRMED VHF
1.
VHFs are severe and life-threatening diseases for which there is no
proven treatment or prophylaxis. Therefore, patients with confirmed VHF
infection should be managed in a specialist high level isolation unit
(HLIU). In exceptional circumstances it may not be appropriate to
transfer patients to an HLIU (see paragraph 26). In this case, the unit
where the patient will be cared for must provide as near as possible
complete containment and the use of enhanced PPE above and beyond
that described in the algorithm. This appendix is specifically for the longterm care of patients with confirmed VHF.
2.
This Appendix does not give advice on the clinical management of such
patients. Clinical management of a patient infected with a VHF should be
undertaken by specialist infectious disease clinicians on a case-by-case
basis, and cannot be prescribed here.
Patient containment requirements
3.
Experts agree that there is no circumstantial or epidemiological evidence
of an aerosol transmission risk from VHF patients. A theoretical risk has
been postulated. Evidence from outbreaks strongly indicates that the
main routes of transmission of VHF infection are direct contact (through
broken skin or mucous membrane) with blood or body fluids, and indirect
contact with environments contaminated with splashes or droplets of
blood or body fluids.
4.
Avoiding contact with a patient’s body fluids, minimising contamination of
the environment, and safely containing contaminated fluids and
materials, is paramount to protecting staff and the wider public against
infection risks.
42
5.
Following a revised assessment of the risks for the transmission of VHF
by the ACDP, this guidance recommends two control options for the
containment and isolation of VHF patients in the UK. These two control
options provide flexibility in the isolation of a patient with a VHF infection
within an HLIU.
6.
Option 1: VHF patients can be completely isolated using a negative
pressure patient isolator (“Trexler”) within a negative pressure isolation
suite. Exhaust air from the Trexler isolator is HEPA filtered, as is the
exhaust air from the isolation suite, providing double HEPA protection.
Staff are protected due to their physical separation from the patient by a
flexible film barrier and an air barrier. Access to the patient is via built-in
access portholes within the flexible film. The patient isolator will contain
all body fluids so contamination of the isolation suite is minimised. Staff
will normally wear theatre blues and gloves where necessary but should
not require additional if this option is used.
7.
Option 2: VHF patients can be isolated within a negative pressure
isolation suite that has an appropriately designed ventilation system
without utilising a Trexler isolator.
Due to the potential for greater
exposure to blood and body fluids as a result of ongoing long-term
patient management of a confirmed case, staff protection must be
provided through the use of enhanced PPE, including Respiratory
Protective Equipment, as follows:

Power-assisted personal respirator with a P3 filter and full hood
(whilst inhalation is not strongly linked to transmissibility of VHF, as
a precaution RPE must be included, see Appendix 8)

Coveralls i.e. all in one water repellent disposable clothing that
covers the whole body;

Full length plastic apron over disposable coverall

Fluid repellent footwear e.g. surgical boots/shoe covers;
43

8.
Double gloves as a minimum.
It is important to ensure that each element of the PPE/RPE ensemble is
compatible to combine adequate protection with user comfort (see
Appendix 8 for more details).
9.
Correct protocols for putting on (donning) and removing (doffing) PPE
and RPE must be strictly adhered to maintain staff protection. More
information on PPE, including RPE, is included in Appendix 8.
High Level Isolation Units (HLIU)
10.
The purpose of an HLIU is the complete containment of patients infected
with an ACDP Hazard Group 4 pathogen. In order to control and contain
the possible spread of the pathogen to healthcare staff, other patients or
the general public, there are a number of structural and operational
requirements that the HLIU must fulfil as described below.
HLIU structural requirements
11.
The unit should be part of a specialist infectious disease unit, sited in an
area away from general circulation or form part of a separate isolation
building. The aim is to:

Achieve complete physical separation of VHF patients to mitigate
against disease spread;

Provide direct access for VHF patients to specialist infectious
diseases clinical expertise;

Ensure security against disruption and crime;

Allow for secure and direct transfer of patients from ambulance to
unit;

Allow for building systems monitoring for the HLIU as a whole;

Construct so as to avoid having walls adjacent to the outside for
rooms in which care is provided or contaminated material is stored
44
i.e. have walls that are internal to the main building to avoid
accidental release.
12.
The unit must be kept at negative pressure relative to the surrounding
area, and patient isolation suites within the unit must also be at negative
pressure relative to the rest of the unit. The direction of air circulating
within the unit should follow a gradation of increased negative pressure
and flow from clean through to contaminated areas, and be HEPA (or
equivalent) filtered before discharge to the atmosphere.
13.
There must be clear segregation of clean and potentially contaminated
areas of the unit. Clearly delineated and separate pathways through the
unit for staff, patients, visitors, supplies and waste should be integrated
into the structural design.
14.
Changing rooms and showers for staff are required within the unit.
Negative pressure ventilation is required within the changing rooms and
showers relative to the surrounding area and must form part of the
gradation of negative pressure within the suite.
15.
All surfaces within the unit must be easy to clean. Floor, walls and other
surfaces must be impervious to water and resistant to damage from
disinfectants.
16.
An autoclave should be installed within the unit.
HLIU design considerations for negative pressure ventilation
17.
Negative pressure ventilation is used to control the direction of airflow
between the patient isolation suite and adjacent areas. Its aim is to
prevent contaminated air from escaping from the isolation suite into
other areas of the unit or beyond. Negative pressure ventilation needs to
45
be carefully and specifically designed in order to achieve the desired
protective effect.
18.
Research studies demonstrate that:

Room sealing (air tightness) must be effective and should be
designed into the construction of the HLIU environment through a
clear specification for ventilation performance. Poor room sealing
results in unpredictable airflow and failure in containment, even if
large negative pressure differentials are used;

Effective sealing of doors is necessary, and door self-closing
devices and interlock arrangements are required to prevent both
loss of negative pressure and containment, and unintended airflow;

All internal and external windows and viewing panels should be
sealed;

A stepped negative pressure approach is recommended with the
highest negative pressure in the patient isolation room, with
progressive decrease in nominal pressures extending outwards to
the periphery of the unit. A well designed stable system could
operate on a 3-step basis at, for example, -40 Pa, -25 Pa and -15
Pa relative to the outside atmosphere in line with movement from
the isolation suite out to the staff circulation and changing facilities
within the unit;

An air change rate of at least 25 air changes/hour should be
provided in those areas where dispersal of contamination is likely to
be the greatest in order to dilute and remove contaminants. This
would apply whether or not a Trexler isolator is used;

Heat from equipment and personnel can adversely affect the air
flow pattern within the room and must be taken into account.
19.
Validation for performance and against technical specification should be
carried out, with re-validation at specified agreed intervals.
46
20.
Environmental monitoring should be built-in to monitor the performance
of negative pressure ventilation systems.
HLIU operational requirements
21.
The unit should have in place detailed written operational policies
covering all activities in the unit. These should include:

Unit activation and deactivation;

Roles and responsibilities of staff;

Patient admittance and discharge;

Staff entry and exit;

Personal Protective Equipment (PPE, see paragraph 19) and
Respiratory Protective Equipment (RPE, see Appendix 8) use,
disposal and storage;

Management of spillages;

Taking of specimens and subsequent handling;

Ambulance and ambulance crew decontamination;

Disinfection, decontamination and terminal cleaning of the unit (see
Appendix 10 of this guidance);

Special arrangements for waste handling, disinfection and disposal
(see Appendix 11 of this guidance);

Special arrangements for laundry (see Appendix 10 of this
guidance);
22.

Emergencies, for example fire or flooding, including evacuation;

Maintenance and repair.
If specialist services such as radiology are necessary, these should be
carried out at the patient’s bedside.
23.
The unit should be staffed by individuals trained in the management of
infectious disease. All staff must receive regular appropriate training and
instruction in use of the high risk facility.
47
24.
Access must be restricted to authorised personnel – the general public,
including patients, relatives and visitors, should be excluded from the
area when the unit is in use. A register of all personnel including clinical,
non-clinical and maintenance staff entering the unit must be kept as a
means of tracking potential exposure to infection.
Managing a VHF positive patient in a non-HLIU environment
25.
In exceptional circumstances it may not be appropriate to transfer
patients to an HLIU. In this case, it is important that advice is sought
from HLIU specialist staff.
The patient must be housed in a single
occupation infectious disease unit side room (‘enhanced single room’),
preferably with a ventilated lobby (isolation suite), with en-suite sanitary
facilities and where complete physical separation from other patients can
be achieved. See Department of Health guidance HBN 4 Supplement 1
- Isolation Facilities in Acute Settings:
https://www.gov.uk/government/uploads/system/uploads/attachment_dat
a/file/148503/HBN_04-01_Supp_1_Final.pdf
26.
Enhanced single rooms will have extract ventilation and operate at
negative pressure relative to the rest of the unit. In isolation suites with a
ventilated lobby, the lobby will be at positive pressure to ensure that air
from the corridor does not enter the isolation room, and that air from the
room does not escape into the corridor. This design enables these suites
to be used for both source and protective isolation. Although this does
not adhere to the stepped negative pressure approach applied in HLIUs,
it provides acceptable containment under exceptional circumstances.
27.
There must be a clear segregation and gradation of clean and potentially
contaminated areas in the room, with PPE changing in the lobby of
48
isolation suites or nearest the door in enhanced single rooms without a
lobby.
28.
An operational policy following the principles described in paragraph 11
must be created, documented and agreed with all staff involved.
Enhanced PPE, including Respiratory Protective Equipment, should
be used as follows:

Power-assisted personal respirator with a P3 filter and full hood
(whilst inhalation is not strongly linked to transmissibility of VHF, as
a precaution RPE must be included, see Appendix 8)

Coveralls i.e. all in one water repellent disposable clothing that
covers the whole body;
29.

Full length plastic apron over disposable coverall

Fluid repellent footwear e.g. surgical boots/shoe covers;

Double gloves as a minimum.
It is important to ensure that each element of the PPE/RPE ensemble is
compatible to combine adequate protection with user comfort (see
Appendix 8 for more details).
30.
Correct protocols for putting on and removing PPE and RPE must be
strictly adhered to maintain staff protection. More information on PPE,
including RPE, is included in Appendix 8.
31.
A segregated holding area for contaminated material must be
designated as near as possible to the side room, with procedures in
place for transfer of material to that area with minimum potential for
cross-contamination.
32.
Procedures must be put in place for disinfection, decontamination and
terminal cleaning as soon as possible following transfer of the patient out
of the isolation suite. See further details in Appendix 10.
49
33.
Procedures must also be put in place for safe transfer of waste from the
holding area to where it will be inactivated.
See further details in
Appendix 11.
50
APPENDIX 5: TRANSFER OF A PATIENT
Transfer of a patient within the UK
1.
Patients without confirmed VHF being transferred between hospitals (not
HLIU) may be transported by standard means provided that they do not
have bruising, bleeding, uncontrolled diarrhoea or uncontrolled vomiting.
2.
The decision to transfer a patient to HLIU should be made by the senior
clinician responsible for the patient’s care, after consultation and
agreement with clinicians at the HLIU to which the patient is to be
transferred. Only patients with confirmed VHF should be transferred to
the HLIU, however in exceptional circumstances patients may be
transferred before the diagnosis is confirmed. The ambulance crew and
staff must be made aware of the patient’s clinical condition.
3.
Transfer by road, in an ambulance, is the preferred option for all
patients. Transfer to the HLIU will be arranged by the HLIU staff. VHF’s
are classified as Category 4 infectious diseases across all Ambulance
Trusts in England, Scotland, Wales and Northern Ireland.
4.
Ambulance Trusts should follow the guidance for category 4 infection
prevention and control measures (IHCD Ambulance Service Basic
Training Manual, 2008. Section 17.5 Category 4 Infections), which
provides clear operational procedures for the transfer of a VHF patient in
the UK. Ambulance crew and staff transferring a VHF patient must be
specifically and adequately trained, and undertake periodic exercises to
test their procedures. It is advisable that regular training exercises with
the HLIU are also performed. Female staff can decline to transfer
patients at Category 4 if they are pregnant.
51
5.
Transportation by Ambulance of patients with a Category 4 infectious
disease will need to be carried out in accordance with a number of basic
requirements for ambulance contents, PPE, decontamination and after
care. These are outlined below.
Ambulance contents
6.
The minimum equipment and supplies necessary for the transfer should
be retained on board – everything else should be removed to reduce risk
of cross contamination. Consideration should also be given to the
location of equipment on board to minimise the potential for
contamination.
PPE
7.
As a minimum PPE should include for a confirmed or of high degree of
suspicion patient the agreed PPE is worn over an appropriate base layer
(such as the cooler layer worn under CR1) and consists of:

Coveralls i.e. all in one water repellent disposable clothing that
covers the whole body including head and neck such as Tyvek or
Tychem F Suit;

A Fit tested FFP3 facemask;

Eye protection;

CR1 boot covers or wellington boots or equivalent
washable/disposable footwear;

Disposable double gloves.
PHE recommend the use of Tyvek/FP3, but if unavailable CR1/FM12 may be
considered.
52
8.
Procedures should be in place for safe donning and removing of the
PPE, including the correct order in which this should be done.
Decontamination of ambulance and equipment
9.
The ambulance should be driven to the decontamination area at the
HLIU and treated as specified in the guidance. All disposable ambulance
equipment, blankets, linen, cloths etc., plus materials used in the
decontamination procedure must be treated as Category A clinical
infectious waste, secured and labelled ‘infectious for incineration’, the
labels endorsed with the patient identifier and disposed of by hospital
staff.
Decontamination of ambulance crew and staff, clothing
10. Decontamination of crew and staff should take place in the HLIU. In
summary this should include the following:

All PPE and disposable items, which must be treated as Category A
clinical infectious waste, removed, bagged and labelled ‘infectious
for incineration’ along with the patient identifier and disposed of by
hospital staff;

Any recoverable items (spectacles, non-disposable contact lenses),
which should be placed in a clear plastic bag and handed to HLIU
staff for decontamination;

Crew members should take a shower including hair wash before
entering the clean area.
After care of ambulance crew and staff
11. All ambulance staff and crew who have been in the ambulance whilst the
patient is being transferred should be identified as contacts and followed
up if the patient is confirmed to have a VHF infection. A contact is defined
as a person who has been exposed to an infected person or their blood
and body fluids, excretions or tissues following the onset of their illness.
53
Guidance on the management of contacts is available in Section 6 of this
guidance.
12. If a member of ambulance crew or staff is accidentally exposed to
potentially infectious material from the patient, this should be reported
immediately. Hospital trust emergency procedures should be followed with
additional advice from the HLIU. Appendix 9 also contains guidance on
accidental exposures.
13. In extraordinary circumstances, transfer of a patient presenting an
enhanced risk to crew and staff (due to bleeding, uncontrolled diarrhoea,
uncontrolled vomiting) could be requested.
In such circumstances,
transfer should be discussed with HLIU who will provide special
instructions and guidance.
14. Further information on ambulance requirements for VHF patient transfer is
available at http://naru.org.uk/wp-content/uploads/2014/08/VHF.pdf.
Transfer by air within the UK
15. Although road transfer is preferable, air transfer may be necessary in
some circumstances.
Following advice and contacts provided by the
receiving HLIU, a patient may be moved by air ambulance with a crew
suitably trained for this.
16. A standard operating procedure has been developed by NHS England
and the Royal Air Force (MoD) to facilitate the transfer of a patient by air
using the Air Transport Isolator.
54
Key points for ambulance crew and staff to remember before
transferring a VHF patient
CHECK:
 that you are trained to undertake a Category 4 infectious disease transfer;
 that you have received full information about the condition of the patient and
the possibility of sudden deterioration during the journey, and that you give
this information to the receiving clinical team;
 the specific arrangements for the journey, including possible escort for long
road journeys
 that you are aware of arrangements in case of an emergency.
ENSURE:
 that you are fully familiar with the procedures necessary for safe transport
 that you maintain close communication with the receiving clinical team at the
HLIU at all times;
 that suitable PPE is worn by all members of ambulance crew and staff at all
times;
 that under no circumstances should direct oral resuscitation be carried out –
a bag and mask should be used to resuscitate patients;
 that no members of staff who have been in contact with the patient leave the
ambulance en route.
55
APPENDIX 6: SPECIMEN COLLECTION
Specimens collected from patients categorised as ‘low possibility of
VHF’
1.
The main risk of infection to the healthcare worker when collecting the
specimens is direct contact with blood or body fluids from the patient.
The risk of exposure to a VHF when collecting specimens from patients
categorised as ‘low possibility’ is small, as an alternative diagnosis such
as malaria is usually found. There are therefore no additional precautions
to be taken for these specimens, above those already in place under
standard precautions. It is not necessary for the managing doctors to
inform the laboratory, as the risk to laboratory staff is extremely low.
2.
Healthcare waste generated as a result of specimen collection from
patients categorised as ‘low possibility of VHF’ must be treated as
Category B infectious waste.
Specimens collected from patients categorised as ‘high possibility of
VHF’
3.
Although the risk of infection from patients categorised as ‘high
possibility of VHF’ many eventually turn out to be low as a result of an
alternative diagnosis for example malaria, until an alternative diagnosis
has been confirmed enhanced standard precautions should be followed
(Section 4). It is important to inform the laboratory, to ensure that (i) the
appropriate laboratory containment (CL2) is in place for specimen
handling and (ii) correct waste disposal procedures are followed. Waste
should be securely stored pending laboratory results. In the event that
VHF infection is confirmed this would require disposal as Category A
waste, otherwise it can be disposed of as Category B.
56
4.
Specimens must be transported to the laboratory using appropriate
precautions i.e. specimens should be carried in suitably sealed
containers.
5.
Healthcare waste generated as a result of specimen collection from
patients categorised as ‘high possibility of VHF’ must be securely stored
pending laboratory results. In the event that VHF infection is confirmed,
this would require disposal as Category A infectious waste, otherwise it
can be treated as Category B waste.
Specimens from patients with confirmed VHF
6.
There are potential risks of infection to the healthcare worker associated
with collecting and handling specimens from patients with confirmed
VHF. The main risk of infection when collecting and handling specimens
is direct contact with blood or body fluids from the patient, for example by
accidental inoculation (needlestick) or contact with broken skin or
mucous membranes.
7.
In patients with confirmed VHF, specimens taken for laboratory analysis
should be kept to the minimum necessary for patient management and
diagnostic evaluation. Specimens should be discussed in advance
between clinicians and the appropriate specialist for each laboratory
area. During specimen collection, standard infection control principles
and practices should always be adopted. In addition, staff must select
PPE in accordance with the risk category of the patient – see the patient
risk assessment algorithm and Section 5 of this guidance and Appendix
8.
8.
Healthcare waste generated as a result of specimen collection from
patients with confirmed VHF must be treated as Category A infectious
waste. Waste should be dealt with according to the guidance set out in
57
“https://www.gov.uk/government/uploads/system/uploads/attachment_da
ta/file/167976/HTM_07-01_Final.pdf” (HTM 07-01) i.e. autoclaved on site
or incinerated (see Appendix 11).
9.
The following principles should be followed to ensure safe transfer of
these specimens to the laboratory:

Laboratory staff should be notified prior to receipt of all specimens
from patients with confirmed VHF;

Specimens must be transported in person i.e. not be sent on
automatic transport systems (e.g. pneumatic transport systems) nor
in standard mail;

Specimens must be transported to the laboratory using appropriate
precautions i.e. specimens should be carried in suitably sealed
containers;
If a member of staff is exposed to body fluids during specimen collection e.g.
accidental percutaneous contamination, or requires information about
decontamination of body fluid spillages, please refer to Appendices 9 and 10.
58
APPENDIX 7: LABORATORY PROCEDURES
1.
There are potential risks of infection to laboratory staff associated with
handling specimens from all types of patient. Patients suspected of VHF
infection are clinically assessed as one of the following categories:

Low possibility of VHF infection;

High possibility of VHF infection;

Confirmed VHF infection;

VHF infection unlikely.
2. For specimens from all patients in whom VHF is being considered,
appropriate risk assessments together with local codes of practice must
be in place. This information can be used to ensure that the risks are
effectively managed; relevant facilities are in place and are managed
properly. The risk assessment should include evaluation of the risks
associated with each analytical technique and the application of
appropriate control measures.
3. Autoanalysers used to process laboratory samples are considered to pose
minimal risk to laboratory staff. Routine processing of samples for each of
the above categories therefore pose no greater risk than samples
containing Hepatitis B, Hepatitis C, HIV and other blood-borne viruses. To
ensure a safe system of work, protocols for machine decontamination,
maintenance, management of spillages and waste disposal must be in
place
and
followed,
taking
into
consideration
manufacturers’
recommendations. Autoanalysers should be disinfected following local
procedures after sample processing and before scheduled maintenance.
59
Specimens from a patient categorised as ‘low possibility of VHF’
4. The overall risk to laboratory workers from specimens from these patients
is considered to be minimal, and specimens may be processed at
containment level 2. Analysis of specimens should not be delayed whilst
awaiting the results of VHF screens. Routine laboratory tests should be
carried out where possible in autoanalysers using standard practices and
procedures at containment level 2.
Specimens from a patient categorised as ‘high possibility of VHF’
5. The overall risk to laboratory workers from specimens from this category
of patient is also considered to be low, and specimens may continue to be
processed (for a restricted list of investigations – see algorithm) at
containment level 2 in routine autoanalysers. Waste from these machines
is not considered to pose a significant risk because of the small sample
size and dilution step and will therefore require no special waste disposal
precautions. Procedures must be in place for the effective management of
spillages (see Appendix 10). A sealed centrifuge bucket or rotor should be
used for centrifugation procedures that are being undertaken manually i.e.
not within an autoanalyser.
6. For specimens categorised as ‘high possibility of VHF’ laboratory staff
should be informed so that original patient specimens can be retained and
provision made for disposal as category A waste in the event that VHF is
subsequently confirmed.
7. When preparing blood film slides for malaria testing consideration should
be given to the potential for splash and therefore should be carried out in
a microbiological safety cabinet or alternatively facial protection should be
used. Blood film slides should be disposed of in a dedicated sharps bin,
which should be retained and processed as category A waste in the event
that VHF is subsequently confirmed in any of the samples. After use, the
60
work surfaces should be treated with 1,000 ppm available chlorine (see
Appendix 10).
Specimens from a patient with confirmed VHF
8. The number of patients with a positive VHF screen in the UK is very low
(~1-2 cases every two years). In most cases, patients with a positive VHF
screen will be transferred to an HLIU and specimens will be analysed at
the dedicated HLIU laboratory. However, where transfer is delayed or
considered inadvisable, the specimens may be processed in a
containment level 2 laboratory using routine autoanalysers provided that
the additional precautions outlined below are followed.
Additional precautions

Experienced laboratory staff should be available to manage the
coordination of testing and liaise where appropriate with other
laboratories.

Specimen cuvettes from routine autoanalysers should be safely
disposed of as category A waste.

A risk assessment should be carried out for test protocols not
undertaken in routine autoanalysers that are likely to result in the
production of splashes or aerosols. Where appropriate, these tests
should be undertaken in a microbiological safety cabinet or other
equipment providing a similar level of protection.

For manual centrifugation procedures, a sealed centrifuge bucket
or rotor must be used.

Patient samples that are not for immediate disposal should be
packed
in
rigid
containers,
which
should
be
surface
decontaminated and retained within the laboratory awaiting safe
disposal.

Disinfection
and
decontamination
procedures,
validated
as
effective against blood-borne viruses, must be in place.
61

Autoanalyser disinfection procedure should be carried out following
sample processing and before scheduled maintenance.

Retained specimens must be disposed of as Category A waste and
inactivated by autoclave.

Blood film slides should be disposed of in a dedicated sharps bin,
which must be processed as category A waste.

Work surfaces should be treated with 1,000 ppm available chlorine
(see Appendix 10).
Specific instructions for speciality areas
9. Automated instruments can be used to process blood cultures for
microbiological analysis; however, care should be taken when subculturing potentially positive specimens and procedures should be
undertaken in a microbiological safety cabinet by experienced staff.
10. If a member of staff is assessed as likely to have been exposed to VHFpositive specimens, they should liaise with their occupational health
provider about following health monitoring (see Appendix 9).
62
APPENDIX 8: PERSONAL PROTECTIVE EQUIPMENT
(INCLUDING RESPIRATORY PROTECTIVE
EQUIPMENT)
1.
Control and containment when managing patients who may have VHF
infection, or confirmed VHF, is important to protect staff and the wider
community. The isolation of the patient in either a single side room or a
negative pressure isolation room, supplemented by appropriate PPE, or
a physical barrier are key risk control measures. To ensure the
effectiveness of PPE, care will need to be taken in its initial selection and
subsequent maintenance, storage and use, as described in this
Appendix.
2.
When selecting PPE, the infection risk, the tasks to be undertaken, the
environment in which the PPE is being used and the person using the
PPE must be considered.
3.
When selecting PPE for protection of healthcare staff the potential
exposure routes to be considered are direct contact (through broken
skin or mucous membrane) with blood or body fluids, and indirect
contact with environments contaminated with splashes or droplets of
blood or body fluids. Regarding VHF infection risk:

transmission has usually been associated with patient care when
appropriate barrier precautions have not been in place to prevent
exposure to blood and other body fluids;

the risk for person-to-person transmission of VHFs is highest during
the later stages of illness, when vomiting, diarrhoea, and often
haemorrhage, may lead to splash and droplet generation.
63
4.
Selection of PPE In patient management, PPE selection should be
proportionate to the likelihood of VHF infection as defined in the viral
haemorrhagic fevers risk assessment (algorithm),Sections 3, 4, 5 and
Appendix 4.
5.
It is important to consider ergonomic factors to give maximum protection
while ensuring minimum discomfort to the wearer.
Uncomfortable
equipment is unlikely to be worn properly. More than one type or size of
PPE may be needed and should be tested to fit the wearer. Some types
of RPE e.g. disposable respirators and half- masks, are not suitable for
staff with beards or facial hair as they will not seal to the wearer’s face,
and achieving a good face fit can be a particular problem for a person
with a small face (see also below).
6.
The PPE selected should be of suitable quality and construction to
provide the required level of protection in the working conditions and
must bear a “CE” mark that signifies compliance with the Personal
Protective Equipment Regulations 2002. This implements the European
PPE Directive concerning design and manufacture and demonstrates
conformance with European (EN) or International (ISO) standards.
7. Further guidance on the selection and correct wearing of RPE is given in
the HSE guidance Respiratory protective equipment at work: A practical
guide. Further information on suitability and instructions for correct use
should be provided by RPE manufacturers.
8.
The PPE should provide suitable barrier protection for staff. The barrier
function will need to be maintained throughout all clinical/nursing
procedures, and when following appropriate procedures for the removal
and disposal or decontamination of potentially contaminated equipment
by the wearer.
64
9.
The PPE/RPE combination has to establish a barrier against contact
with contaminated surfaces, splash, spray, bulk fluids and aerosol
particles as follows:

Should provide adequate coverage of all exposed skin, with
sufficient integrity to prevent ingress or seepage of bulk liquids or
airborne particles, under foreseeable conditions of usage;

The materials from which the PPE is made should resist
penetration of relevant liquids/suspensions and aerosols;

The various components (body clothing, footwear, gloves,
respiratory/face/eye protection) should be designed to interface
sufficiently well to maintain a barrier, e.g. sleeves long enough to
be adequately overlapped by glove cuffs.
Respiratory Protective Equipment
10. There is no circumstantial or epidemiological evidence of airborne
transmission risk from VHF patients. However, as a precautionary
measure it is considered appropriate to wear RPE to a high level
Assigned Protection Factor when managing a confirmed case of VHF.
This will usually be provided by a powered hood type respirator in
specialist centres; the use of a disposable filtering face-piece (FFP)
respirator type EN 149 FFP3, certified as PPE under the European
Directive 89/686/EEC can be considered as an alternative.
11. When using FFP3 respirators it is important that wearers have
undergone face-fit testing to ensure such respirators achieve a good
seal as required under the Control of Substances Hazardous to Health
(CoSHH) 2002 as amended.
While disposable RPE may be more
practical to avoid the need for decontamination of re-usable RPE, facial
hair (a beard or stubble) may prevent a good seal being achieved with a
disposable respirator. In this instance a powered hood type respirator
given a classification of TH2 according to European Standard EN 12941
may be necessary. Likewise, certain face shapes may prevent a good
65
seal being achieved with a disposable respirator, but in this case a half
mask re-usable respirator with P3 filter may be a practical solution.
Donning and doffing PPE
12. As described above, PPE should be chosen to ensure an adequate
barrier to exposure is created and maintained. This will need to be taken
into consideration when putting on the various items of PPE. After use,
it should be assumed that PPE may be contaminated and an appropriate
removal procedure is essential to prevent risks of exposure to the
wearer. Consequently, a detailed and pre-defined sequence for donning
and doffing items should be developed, implemented and monitored.
13. Staff should be trained in procedures to don and especially doff PPE,
including the correct order to avoid cross contamination, and to check
that the RPE with which they are provided fits properly. They must also
receive clear instructions on when it is to be used and how it is to be
disposed of or, as appropriate, decontaminated, maintained and stored.
This training should be held regularly and training records should be kept
for all participating individuals.
14. PPE should be donned before starting procedures likely to cause
exposure and only doffed after moving away from a source of exposure.
15. PPE should not be a source of further contamination e.g. by being
removed and left on environmental surfaces.
16. Further detailed guidance on safe donning and doffing can be found in
PHE VHF emergency department PPE dressing procedure (add link or
further info).
Disposal or decontamination
17. Following removal, disposable PPE will need to be placed into suitable
disposal receptacles and treated as clinical infectious waste. If re-usable
66
PPE is unavoidable, it must be decontaminated using an appropriate
method prior to storage. The method should be validated as effective
against VHF (see Appendix 10) and compatible with the PPE to ensure it
is not damaged so that its effectiveness in subsequent use is not
compromised.
Storage and Maintenance
18. PPE should be suitably stored to prevent accidental damage and
contamination.
Infrequently used PPE should be subject to stock
selection and control procedures with regard to shelf-life to ensure it is
available for use at short notice with no deterioration in protective
qualities. RPE requiring powered respirator units should be thoroughly
examined, tested and maintained at suitable intervals (at least once a
month). Records of the tests must be kept for at least five years after
the date of the test.
67
Summary of good practice in the use of PPE/RPE

PPE must be appropriate, fit for purpose and suitable for the person
using/wearing it. A scheme for periodical repetition of face fit testing (either
annually, due to change of facial features, or alteration to respiratory
function) should be developed and implemented;

Training must be provided with consideration of susceptibility to human
error;

A strategy for implementing and monitoring the correct use of PPE which
could include visual check, cross check or supervision by responsible
person should be developed;

A detailed and pre-defined sequence for donning and doffing items should
be developed, implemented and monitored;

PPE should be located close to the point of use;

PPE should not be a source of further contamination e.g., by being
removed and left on environmental surfaces, or by being removed
inappropriately thus contaminating the wearers hands;

The use of PPE such as gloves does not negate the need for hand
hygiene;

The integrity of PPE should not be compromised during nursing
procedures. It might otherwise potentially lead to exposure to blood or
body fluids. For example solvents or certain products such as hand creams,
can affect integrity;

There should be validated procedures for the disinfection of re-useable
PPE;

Stocks of PPE should be stored off the floor, e.g., on appropriate shelving
in a designated, clean and dry storage area to ensure that they are not
contaminated prior to use.
68
APPENDIX 9: MANAGEMENT OF STAFF
ACCIDENTALLY EXPOSED TO POTENTIALLY
INFECTIOUS MATERIAL
1.
Procedures must be in place to deal with any accidental exposure of staff
to blood or body fluids from high possibility or confirmed cases of VHF.
2.
Accidental exposures that need to be dealt with promptly are:

percutaneous injury e.g. needlesticks:
Immediately wash the affected part with soap and water. Encourage
bleeding via squeezing.

contact with broken skin:
Immediately wash the affected part with soap and water.

contact with mucous membranes (eyes, nose, or mouth):
Immediately irrigate the area with emergency wash bottles, which
should be accessible in case of such an emergency.
3.
In all cases, the incident will need to be reported and the individual
referred urgently to the local Clinical Virologist, Clinical Microbiologist or
Infectious Disease Physician, and their occupational health provider.
4.
In the event that VHF infection is confirmed in the source patient, the
exposed individual should be followed up as a Category 3 contact – see
Section 6 for details. In Great Britain, the incident may need to be
reported under Reporting of Injuries, Diseases and Dangerous
Occurrences
Regulations
2013
(RIDDOR)
to
HSE
(http://www.hse.gov.uk/riddor/). In Northern Ireland, it may need to be
reported under RIDDOR (NI) to HSENI (http://www.hseni.gov.uk/). Under
RIDDOR, a definite exposure would be reported as a dangerous
occurrence, whereas if the staff member actually acquired an infection it
would need to be reported under the occupational disease category.
69
APPENDIX 10: DECONTAMINATION, INCLUDING
TREATMENT OF LAUNDRY
1.
VHFs are enveloped viruses. This type of virus has been shown to be
susceptible to a broad range of disinfectants including chlorine and
alcohol, and to thermal inactivation (1 hour at 58 – 600C, or 30 minutes
at 750C). There is no evidence to suggest that they have any greater
resistance to inactivation than other enveloped or blood borne viruses
such as HIV.
Therefore it can be assumed that decontamination
methods used against blood borne viruses will be effective.
2.
Survival of viruses outside the body is dependent on several factors. For
example, Ebola virus survival on different surfaces is dependent on a
number of environmental factors (type of surface, humidity, light,
concentration of virus present, etc.). It can survive for several hours
when dried onto surfaces such as doorknobs and worktops, and up to
several days in body fluids such as blood at room temperature. However
it is easily inactivated at higher temperatures and by soap and water.
3.
For patients categorised as low possibility of VHF, standard precautions,
cleaning and decontaminating procedures apply, including the treatment
of laundry. All procedures should be in keeping with those used when
caring for a patient with malaria.
4.
The information in this Appendix applies to those patients who have
been categorised as high possibility of VHF or have been confirmed with
VHF infection.
5.
Staff should ensure that areas and equipment used for the care of
patients who have been categorised as high possibility of VHF or have
been confirmed with VHF infection are decontaminated and cleaned
70
following the procedures in this Appendix. Decontamination and cleaning
must be conducted wearing appropriate PPE (see Appendix 8 for
general principles and apply local rules for specific PPE and
procedures). For information on decontamination of ambulance vehicles
see IHCD Ambulance Service Basic Training Manual, 2008. Section 17.5
Category 4 Infections.
6.
It is important to ensure that products used in the decontamination
procedure have been validated as effective against blood-borne viruses.
Control measures against such viruses in clinical settings are described
in recently updated ACDP guidance on blood-borne viruses.
71
Bleaches, hypochlorites and chlorine releasing agents
In various protocols and guidance, reference will be made to bleach or
hypochlorite solution. To clarify:

The active disinfectant component of bleach is sodium hypochlorite
(NaOCl).

Typical household bleach is a solution of sodium hypochlorite generally
containing 50,000ppm (5%) available chlorine.

It is important to check the concentration in the formulation before use, as
it is likely to require dilution.

The strength of the bleach may reduce with long-term storage.

Typical in-use concentrations are 10,000ppm (1%; 1 in 5 dilution of
typical bleach) for the disinfection of blood-spills and 1,000ppm (0.1%; 1
in 50 dilution of typical bleach) for general environmental cleaning.

Sodium dichloroisocyanurate (NaDCC) may be used as an alternative to
NaOCl. This is also available in granule form, which may be practical to
absorb, contain and disinfect spills. Refer to suppliers’ instructions for inuse concentrations.

Note that there is a minimum contact time for chlorine-based absorbent
granules. This contact time is usually 2 minutes, but may vary from
product to product.

Gloves should be suitable for use and inspected before they are put on to
ensure that they are intact. Where the task involves using chemicals such
as chlorine-based products, the gloves should be certified as suitable for
chemical resistance and comply with the PPE directive (refer to the
healthcare cleaning manual).

Ensure adequate ventilation when disinfecting areas with chlorine-based
products i.e. open windows or doors where necessary.
Recommended procedures when there has been no obvious
contamination by blood and/or body fluids
7.
Validated standard washing and cleaning methods can adequately treat
areas and equipment, which have not been contaminated with blood,
body fluids or laboratory specimens.
72
Recommended procedures when there has been contaminated by blood
and/or body fluids
8.
VHF viruses have been known to survive for two weeks or even longer
on contaminated fabrics and equipment.
Persons carrying out
decontamination and cleaning procedures must wear appropriate PPE
and use suitable disinfectant products determined by a robust risk
assessment. Refer to Info box on spillages of blood and body fluids.
Crockery and cutlery
9.
Disposable crockery and cutlery should be used where possible for those
patients categorised as high possibility or confirmed VHF. Subject to risk
assessment, these items should be disposed of as category A waste.
Toilets
10. Toilets or commodes may be used by patients categorised as ‘high
possibility’ or ‘confirmed’ for VHF infection. Where commodes are
employed, a dedicated commode should be used with a disposable bowl.
After use, the contents are to be solidified with high-absorbency gel and
then autoclaved or incinerated. Toilets and commodes should be
disinfected with hypochlorite containing 10,000ppm available chlorine at
least daily, preferably after each use, and upon patient discharge. For
non-ambulant patients, disposable bedpans should be used and the
contents to be solidified with high-absorbency gel and then autoclaved or
incinerated.
Treatment of Laundry
Use and treatment of disposable linen
11. The use of disposable linen should always be considered when
appropriate, in particular when caring for a patient with a ‘high possibility
of’ or ‘confirmed’ VHF infection. Subject to risk assessment, this linen
may need to be treated and disposed of as category A waste.
73
Use and treatment of non-disposable linen
12. All re-useable linen from patients with a ‘high possibility’ or ‘confirmed’
for VHF infection should not be returned to a laundry and must therefore
be treated and disposed of a category A infectious waste as set out by
Health Technical Memorandum HTM 07-01 Safe Management of
Healthcare Waste
https://www.gov.uk/government/uploads/system/uploads/attachment_dat
a/file/167976/HTM_07-01_Final.pdf
Terminal disinfection of HLIU or IDU
13. Following VHF positive patient discharge, HLIU wards will be
decontaminated by fumigation. Rooms used to house VHF positive
patients in an (non-specialist) IDU will need to be decontaminated via
fumigation (see info box on room fumigation below). This will need to be
carried out following a thorough risk assessment. Procedures for
decontamination will be established in consultation with HLIU staff.
74
Spillages of blood or body fluids
For small spots of blood or small spills:

Gloves should be worn and lesions on exposed skin covered with waterproof
dressings;

Contamination should be mopped up with absorbent material (e.g. disposable
paper towels), which are then disposed of through the correct waste stream;

The area should then be disinfected with freshly prepared hypochlorite solution
containing 1,000ppm available chlorine (0.1%; 1 in 50 dilution of typical bleach)
ensuring a contact time of two minutes before wiping up with disposable paper
towels;

The surface should then be washed with warm water and detergent;

All waste, including gloves and paper towels, should be autoclaved or
incinerated.
For larger spills:

The procedure followed should be as per small spills, however, the following
additional measures may be required:

Where possible, allow any potential aerosols to settle out;

It may be necessary based on a risk assessment to wear disposable plastic
overshoes or rubber boots;

If splashing is likely to occur while cleaning up, other appropriate PPE should be
worn;

Towels, gloves, disposable overshoes and any contaminated clothing should be
autoclaved or incinerated, according to local protocols. Rubber boots may be
cleaned then disinfected with hypochlorite solution containing 10,000ppm
available chlorine (1%; 1 in 5 dilution of typical bleach).
75
Room fumigation

In order to ensure successful room decontamination, gross contamination will
need to be cleaned and disinfected appropriately prior to the fumigation
process (refer to box above on spillages).

The fumigant and fumigation process used should be validated for use. . For
example, vaporised hydrogen peroxide and formaldehyde are known to be
effective.

Service engineers / staff undertaking the fumigation process must be fully
trained to do so and maintain infection control procedures when preparing the
room for fumigation.

Rooms to be fumigated must be suitably sealed so as to prevent leakage of
fumigant into unwanted areas. Specialist advice may be required for
fumigation of IDU.

It may be necessary to move nearby patients to a more suitable location
during the fumigation procedure.

Air outside the room being fumigated must not contain levels of fumigant
above the Workplace Exposure Limit (WEL) and as such should be
monitored to ensure the room has been adequately sealed.

Post fumigation, levels of fumigant within the now decontaminated room must
be below the WEL before re-entry. Where this is not possible e.g. where
windows are required to be opened for ventilation purposes, suitable PPE
including RPE must be worn following a risk assessment;

Post fumigation, rooms should be cleaned following locally established
protocols.
76
APPENDIX 11: WASTE TREATMENT AND DISPOSAL
1.
The Department of Health (DH) Health Technical Memorandum HTM 0701
Safe
Management
of
Healthcare
Waste
https://www.gov.uk/government/uploads/system/uploads/attachment_dat
a/file/167976/HTM_07-01_Final.pdf
contains
comprehensive,
best
practice guidance on the management of all types of healthcare waste in
the UK, including waste that is highly infectious.
2.
All waste from patients classified as ‘low possibility of’ having a VHF
infection should be treated as category B infectious waste.
3.
All waste from patients classed as ‘high possibility of’ or ‘confirmed’ VHF
infection is classified as Category A infectious waste, on the basis that it
is known or suspected to be contaminated with pathogens presenting the
most severe risk of infection. All treatment, disposal and transport of
waste should therefore follow the guidance for Category A infectious
waste as set out in HTM 07-01, i.e. autoclaved on site or sent for
incineration.
Inactivation of waste on-site
4.
As far as reasonably practicable, Category A infectious waste should be
treated on-site prior to transport to a disposal facility. On-site treatment
will in most cases involve the autoclaving of waste in purpose-built
facilities (e.g., dedicated autoclaves in HLIUs). However, in the case of
other infectious disease units or hospital ward environments, an
assessment will need to be made of reasonably practicable means for
safe storage and disposal dependent upon such factors as:

The volume of waste;

The availability and practicality of on-site autoclaving;
77
5.

The availability of secure storage;

Safe methods of transfer off site –see below
Before transporting waste to a remote autoclave, arrangements to
coordinate transport should be put in place. Waste should be contained
within two layers of containment with the secondary containment being
robust, leak-proof containers with a secure lid, transported on a trolley
where appropriate. Autoclavable bags should be used as the primary
containment. Waste should be transported direct to the autoclave for
immediate treatment, thus avoiding storage in the autoclave room or in
communal areas.
6.
Autoclave cycles must be appropriately validated to ensure that the
required temperature and pressure conditions are reached for the
appropriate length of time. Autoclaves must comply with British Standard
BS
2646-1:1993
(Autoclaves
for
sterilization
in
laboratories.
Specifications for design, construction, safety and performance) and
must be maintained according to the Pressure Systems Safety
Regulations 2000.
7.
After autoclaving, waste is no longer considered to be infectious and
should be classed as EWC Non-hazardous 18.01.04 “offensive waste”,
which can be disposed of via landfill or municipal incineration/energy
from waste as described in HTM 07-01.
8.
Waste water can be safely disposed of through sanitary sewers without
the need for additional water treatment on the basis that the volume of
effluent will be smalland the survival time of the virus in the sewerage
system is likely to be short.
78
9.
Any liquid effluent that does not go into a lavatory plumbed into the
sewerage system should however be stored in a sealed, leak proof
container and disposed of as Category A waste. If possible, contents
should be solidified with high-absorbency gel.
Laboratory waste
10.
The infectious component of laboratory waste can be classified as either
Category A (specimens from patients classed as ‘high possibility of’ or
‘confirmed’ VHF infection) or Category B (specimens from patients
classed as ‘low possibility of’ VHF infection) as set out in HTM 07-01.
The exception to this is waste from autoanalysers. Waste from these
machines is not considered to pose a significant risk because of the
small sample size and dilution step and will therefore require no special
waste disposal precautions.
11.
Irrespective of whether the infectious waste is categorised as A or B, all
cultures of pathogens should be inactivated on site prior to final disposal
because of the increased risk of exposure associated with higher
concentrations of biological agents. Further detailed guidance on the
handling of laboratory waste can be found in the relevant section of HTM
07-01.
Inactivation of waste off-site
12.
It is recognised that it may not always be reasonably practicable to
autoclave on-site the large volumes of waste generated during the
clinical care of a patient. Other exceptional circumstances could involve
autoclave malfunction. In these circumstances, waste should be
packaged for carriage and transferred to an incinerator as soon as
possible. Waste (including sharps receptacles) must be placed in
appropriate yellow UN-approved packages for transport.
79
13.
A reputable and licensed waste contractor must undertake transport to
the incinerator. Adequate contingency arrangements should be made in
advance with the contractor to ensure safe collection, transport and
disposal demonstrably in full compliance with The European Agreement
concerning the International Carriage of Dangerous Goods by Road
(ADR).
14.
Prior to collection by the contractor, waste must be stored securely and
access restricted to authorised and trained personnel.
15.
For UN classification and packing groups:
ADR Class 6.2: Infectious substances

Category A infectious waste will require UN No. 2814 ‘infectious
substance, affecting humans’. Waste in this category must be packaged
in accordance with P620 of ADR.

Category B infectious waste will require UN No. 3291 ‘clinical waste,
unspecified, N.O.S’, or ‘(bio) medical waste N.O.S.’, or ‘regulated
medical waste, N.O.S.’. Waste in this category must be packaged in
accordance with P621 or LP621 or IBC620 of ADR.

Decontaminated medical and clinical wastes that previously contained
infectious substances will not be subject to the provisions of ADR
unless they meet the criteria for inclusion in another class.
16.
Guidance on the transport of clinical waste in the UK is provided by the
HSE: http://www.hse.gov.uk/cdg/manual/clinical/index.htm
Bulk transport
17.
Special provisions under ADR allow for the carriage of Category B
infectious waste in bulk in specially equipped vehicles and containers “in
80
a manner which avoids risks to humans, animal and the environment,
e.g., by loading the waste in bags or by airtight connections”.
18.
If unavoidable circumstances require Category A infectious waste to be
transported in bulk, then authorisation must be sought from the
Dangerous Goods Division at the Department for Transport (England,
Wales and Scotland) or from HSENI (Northern Ireland).
19.
Waste bags must be UN approved, comply with BS EN ISO 7765:2004
and BS EN ISO 6383:2004, and be marked accordingly.
20.
Prior to transport the detailed requirements of ADR and HTM 07-01
should be discussed with the waste contractor and then implemented in
full and regularly monitored throughout the operation.
81
APPENDIX 12: AFTER DEATH CARE
Post-mortem examination
1.
A post-mortem examination on a person known to have died of VHF
exposes staff to unwarranted risk and should not be performed.
2.
Where a patient suspected of having VHF dies prior to a definitive
diagnosis, it may be necessary on public health grounds to undertake
some diagnostic tests to either establish or eliminate the diagnosis of
VHF or to provide an alternative diagnosis including e.g. malaria.
Consultation with appropriate specialists may help to determine the
extent of the limited amount of sampling that will suffice such an
assessment.
3.
Personnel undertaking diagnostic tests must wear appropriate PPE
following the guidance for safe collection and transport of specimens.
Where the deceased is in a Trexler isolator, the specimens should be
taken before transferring the body to a leak-proof body bag. Where the
results of such tests have found the deceased to be negative for VHF
then a post mortem may be required.
Disposal of the deceased
4.
Where a confirmed VHF case has died whilst being cared for in an
isolator, the body should be removed into a sealable plastic body bag
(specially designed for use with the isolator) fitted to the port of the bed
isolator. The bag should be sealed, separated from the isolator, labelled
as high-risk of infection and then placed in a robust coffin, which will
need to have sealed joints. It should then be kept, by special prior
arrangement with mortuary staff, in a separate and identified cold store
unit to await prompt cremation or burial.
82
5.
An infection control notification sheet should be completed in readiness
for the funeral directors. Once sealed as above, the coffin and body bag
should not be opened. Only in exceptional circumstances should the
coffin or body bag be opened and only then by a designated person after
consultation, and with the authority of, the Consultant in Communicable
Disease Control (CCDC) (in England, Wales and Northern Ireland) or
the NHS Board Consultant in Health Protection (in Scotland).
6.
Where the body of a confirmed or suspected VHF patient is not in an
isolator, staff wearing suitable PPE/RPE (see Appendix 8) should place
the body in a double body bag. Absorbent material should be placed
between each bag, and the bag sealed and disinfected with 1000 ppm
available chlorine or other appropriate disinfectant. The bag should be
labelled as high risk of infection and placed in the coffin as described
above. An infection control notification sheet should be completed in
readiness for the funeral directors.
Public health and controlling the risk of exposure
7.
Under public health law, every person having the charge or control of
premises in which is lying the body of a person who has died while
suffering from a notifiable disease such as VHF must take such steps as
may be reasonably practicable to prevent persons coming unnecessarily
into contact with, or proximity to, the body.
8.
In England, the Health Protection (Local Authority Powers) Regulations
2010, and in Wales, the Health Protection (Local Authority Powers,
Wales) Regulations 2010, grant discretionary powers to local authorities
to restrict contact with, and access to, an infected dead body where
necessary. In Scotland, Part 6 (Protection of public from risks arising
from bodies) of the Public Health etc. (Scotland) Act 2008 grants powers
to health boards to restrict the release of infected bodies from hospitals.
In Northern Ireland the Public Health Act (Northern Ireland) 1967 grant
83
powers to the Director of Public Health to prohibit persons coming into
contact with a body of a person who has died while suffering from a
notifiable disease.
Funeral directors and embalmers
9.
Funeral directors will need to be consulted beforehand and provided with
sufficient information of the infection risk normally provided by an
infection control notification sheet.
10. It is recognised that in most other circumstances in this country, bodies
often receive some form of hygienic preparation or are fully embalmed as
a means of delaying putrefaction (e.g. when the funeral is delayed or for
transportation over long distances within the UK or internationally).
However in the case of confirmed VHF cases, embalming or hygienic
preparation of bodies presents an unacceptably high risk and should not
be undertaken.
Religious/ritual preparations, viewing of the deceased and funeral
arrangements
11. Exceptions to the above include necessary preparation of bodies for
other safety reasons. For example, it is a requirement to remove
pacemakers and some other implants before cremation. In addition to
the information provided on the infection control notification sheet, it is
advised that the funeral director discusses appropriate infection
control procedures, use of personal protective equipment and waste
disposal arrangements with specialists (CCDC and HLIU consultants).
12. As far as is reasonably practicable the needs and wishes of the
deceased’s family should be respected. However, the serious nature of
this infection and the associated occupational and public health risks
necessarily impose significant limitations and constraints, which aim to
limit contact with the body by the next of kin. Due to the unusual
84
circumstances, there will be a need to communicate sensitively that the
following will need to be avoided: religious/ritual preparation of the body,
washing, dressing and viewing, touching or kissing of the deceased.
Repatriation/expatriation of the deceased’s remains
13. In general, the transportation of human remains to or from the UK is
governed by a number of authorities:

The receiving country (normally regarded as being the body of law
that controls how the remains should be handled as regards
control of infection);

The country of origin; and

The carrier – whose requirements will be governed by the
International Air Transport Association (IATA) Restricted Articles
Regulations,
under
which
human
remains
need
to
be
accompanied by a notification of infection form or “free from
infection” certificate.
14. VHF infected bodies should not be embalmed on grounds of risk (see
above), and both for this reason and because of the consequent difficulty
there would be in achieving full compliance with IATA requirements, the
transportation of bodies out of the country is not recommended.
However, following cremation, ashes may be safely transported.
15. In the unlikely event of a VHF infected body being embalmed abroad and
transported back to the UK, it would need to be contained within a sealed
zinc lined transport coffin in accordance with IATA requirements. Upon
arrival in the UK a change of coffins is to be avoided and this may dictate
the options for burial or cremation, which should be promptly arranged.
85
The return of the deceased’s clothing and personal effects to relatives
16. The family of the deceased should be consulted and as far as is
reasonably practicable their needs and wishes should be respected. In
principle clothing, personal effects and valuables may be returned to
relatives in accordance with normal health service procedure following
decontamination.
17. However:

Items of clothing visibly contaminated should be safely disposed
of, other items of clothing should be autoclaved prior to
laundering;

Wedding rings, jewellery and other physical artefacts should either
be autoclaved or decontaminated using a validated disinfectant.
18. With customary sensitivity and respect for the dignity of the bereaved,
relatives should be alerted that some clothing fabrics and materials from
which personal effects are made (e.g. plastics) may be adversely
affected or even destroyed by autoclaving or disinfection (hypochlorite,
the disinfectant of choice is a powerful bleach). In such cases, with the
agreement of relatives, subsequent disposal may be the preferred
option.
86
APPENDIX 13: RELEVANT HEALTH AND SAFETY
LEGISLATION
The legislation framework in the UK
1.
This Appendix is a summary of UK health and safety legislation and
guidance relevant to working in healthcare with patients infected with
VHF, or in laboratories with specimens potentially contaminated by
haemorrhagic fever viruses.
Primary
Health and Safety at Work Act 1974
Legislation
Health and Safety at Work (Northern Ireland) Order 1978
General
Health and
Safety
Regulations
Control of Substances
Management of Health and
Hazardous to Health
Safety at Work Regulations
Regulations 2002
1999
Control of Substances
Management of Health and
Hazardous to Health
Safety at Work Regulations
Regulations (Northern
(Northern Ireland) 2000
Ireland) 2003
Specific
Reporting of Injuries,
Health and
Diseases and Dangerous
Safety
Occurrences Regulations
Regulations
2013
Carriage of Dangerous Goods
and Use of Transportable
Pressure Equipment
Reporting of Injuries,
87
Diseases and Dangerous
Regulations 2009
Occurrences Regulations
(Northern Ireland) 1997
Guidance
From ACDP
Healthcare
Laboratories
Infection at work: Controlling the risks, A guide for
employers and the self employed on identifying, assessing
and controlling the risks of infection in the workplace
Biological agents: Managing the risks in laboratories and
healthcare premises
The management, design and
From HSE
operation of microbiological
containment laboratories
Safe working and the
prevention of infection in
clinical laboratories and similar
facilities
Bloodborne viruses in the workplace: Guidance for
employers and employees
88
Controlling the risks of
infection at work from
human remains
Safe working and the
prevention of infection in
the mortuary and postmortem room
From DH
Safe management of
healthcare waste
Other relevant
guidance
2.
The Health and Safety at Work etc. Act (HSWA) 1974 is the primary
piece of legislation covering occupational health and safety in the UK.
Under HSWA, employers have a duty to provide a safe place of work
and protect the health and safety of their employees and others that may
be affected by their work activities. It also places duties on employees to
cooperate with their employer, so far as is necessary, to enable their
employer to comply with their health and safety duties as set down under
HSWA and under relevant legislation.
3.
The Control of Substances Hazardous to Health Regulations
(COSHH) provide a framework of actions designed to control the risk
from a range of hazardous substances including biological agents. In
particular, Schedule 9 specifically refers to biological agents which
include the VHF viruses.
89
4.
Under the Management of Health and Safety at Work Regulations
and COSHH, once a risk assessment has been completed methods
must be chosen to adequately control the identified risks following a
hierarchical approach of:

Eliminating risk

Controlling risk at source or by safer design

Using physical engineering controls and safeguards; Supported
by:
5.

Safe systems of work

The use of personal protective equipment.
These Regulations require employers to assess the risk of infection for
both their employees and others who may be affected by the work, for
example, waste disposal workers, service engineers and members of the
public. When a risk has been identified, there is a duty to select and
properly apply appropriate prevention or control measures. Engineering
controls used, such as microbiological safety cabinets, must be kept in
efficient working order and good repair and regularly maintained.
Personal protective equipment must be properly stored, cleaned,
maintained and, if found to be defective, repaired or replaced.
6.
COSHH requires that employers take all reasonable steps to ensure that
the control measures they provide are used, which includes provision of
information and training, as well as appropriate supervision of
employees. Risk assessments must be reviewed regularly and revised
when conditions change, an incident occurs, a deficiency is noted or if for
any other reason it is suspected that the assessment is no longer valid.
In addition, employees must receive suitable and sufficient information,
instruction and training about the risks they may encounter at work.
Subject to assessment, there may also be the need to provide health
surveillance for employees and offer them vaccines.
90
7.
Other health and safety regulations may apply, for example equipment
provided must meet the requirements of the Provision and Use of Work
Equipment Regulations (PUWER), i.e. suitable and safe for use, and
safely maintained.
In this context, equipment also includes needles.
Laboratory equipment such as autoclaves must comply with the
Pressure Equipment Regulations 1999 and the Pressure Systems
Safety Regulations 2000.
8.
Under the Reporting of Incidents, Diseases and Dangerous
Occurrences Regulations (RIDDOR) there is a requirement for
employers to report 'acute illness which requires medical treatment
where there is reason to believe that this resulted from an exposure to a
biological agent or its toxins'. They must also report 'any infection reliably
attributable to the performance of particular work, specified as being
work with micro-organisms; work with live or dead human beings in the
course of providing any treatment or service or in conducting any
investigation involving exposure to blood or body fluids; work with
animals or any potentially infected material derived from any of the
above'. There is also a duty to report any 'accident or incident, which
resulted or could have resulted in the release or escape of a biological
agent likely to cause severe human infection or illness' and 'any viral
haemorrhagic fever on offshore workplaces'.
9.
The Carriage of Dangerous Goods and Use of Transportable
Pressure Equipment Regulations 2009 stipulate requirements for
secure packaging and clear hazard labelling that are applicable to the
safe transfer of specimens potentially contaminated by haemorrhagic
fever viruses.
Summary of responsibilities for health and safety
10. The employer will need to:
91

ensure the organisation has the necessary management
framework to protect the health and safety of staff and to provide
a safe working environment;

have access to competent help in applying the provision of
health and safety law;

consult with employees’ safety representatives on health and
safety matters;

establish procedures to be followed by any worker if situations
presenting serious and imminent danger were to arise;

co-operate and co-ordinate where two or more employers or
self-employed persons share a workplace;

make health and safety policy and local codes of practice freely
accessible either by putting them on display or by individual
issue, and ensure all staff, including all newcomers and
temporary workers are aware of them;

manage and follow-up recognised dangerous occurrences,
accidents or incidents at work which could result in the release
of a biological agent likely to cause severe human illness or
infection, e.g., sharps injuries during surgical and needle-related
procedures, including reporting under RIDDOR;

keep health records in relation to work involving risk of exposure
to VHF;

provide proactive health surveillance for occupations where
contact with known or suspected VHF infected patients, or with
VHF contaminated materials, is likely.
11. Specifically for VHF this should include information on:

Whether employees could be exposed to VHF and how;

The risks posed by this exposure;

The main findings of any risk assessment;

The precautions employees should take to protect themselves
and other employees, contract staff or visitors;
92

How they should use and dispose of any PPE that is provided;
and

What procedures they should follow in the event of an
emergency.
12. The employee will need to:
a. comply with agreed risk assessments following the COSHH
hierarchy;
b. adhere to agreed safe systems of work, e.g., laboratory rules,
sharps and waste disposal polices, decontamination and
disinfection procedures;
c. properly use the control measures provided by their employers,
including personal protective equipment (PPE), and report any
problems with them;
d. bring to the attention of their employers any instances of
dangerous occurrences, accidents or incidents arising out of
their work which could result in the release of a biological agent
likely to cause severe human illness or infection, or a sharps
injury involving a known VHF infected source so that necessary
remedial or preventative actions can be taken, including
reporting under RIDDOR.
93
APPENDIX 14: GLOSSARY
Active monitoring: Clinical decision that the patient will remain under the
care of a consultant or NHS Allied Health Professional Service, possibly whilst
the patient receives symptomatic support, but without any specific or
significant clinical intervention at this stage.
Aerosol: Suspension of small or liquid particles in air which are so small and
light that they take very long time to settle out.
Aerosol-generating procedure: A procedure that stimulates coughing and
promotes the generation of aerosols.
Aerosolized or nebulised medication administration: The administration of
medication via air particles or aerosols, delivered by an appropriate device,
which is inhaled and absorbed into the patient’s body via the lungs.
Aerosol/ Airborne transmission: A transmission mechanism in which the
infectious agent is spread as an aerosol that usually enters a person through
the respiratory tract.
Ambulance Category 4 infectious disease: Diseases that require a special
(category 4) infection control measure for ambulance transfer. Currently,
these diseases include rabies, plaque, Lassa fever, Marburg, Ebola and
Crimean/Congo haemorrhagic fever.
Assigned protection factor: The level of respiratory protection that can
realistically be expected to be achieved in the workplace by 95% of
adequately trained and supervised wearers using a properly functioning and
correctly fitted respiratory protective device.
Autoclave: A strong, pressurised, steam-heated vessel for sterilisation.
Available chlorine: The measurement of the oxidising capacity of a
hypochlorite solution.
Category 1 contact: A contact that is not at risk of becoming infected i.e. has
not had direct contact with contaminated body fluids or other potentially
infectious material.
94
Category 2 contact: A contact that is at a low risk of becoming infected i.e.
has had direct contact with contaminated body fluids or other potentially
infectious material whilst wearing appropriate PPE.
Category 3 contact: A contact that is at high risk of becoming infected i.e.
has had unprotected exposure of skin or mucus membrane to potentially
infectious body fluids or other potentially infectious material.
Category A infectious waste: Waste that is known or suspected to be
contaminated with pathogens presenting the most severe risk. A list of such
pathogens can be found in Health Technical Memorandum HTM 07-01 Safe
Management
of
Healthcare
Waste
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/
167976/HTM_07-01_Final.pdf.
Category B infectious waste: Waste that is known or suspected to be
contaminated with pathogens not listed for inclusion into category A waste
(Health Technical Memorandum HTM 07-01 Safe Management of Healthcare
Waste
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/
167976/HTM_07-01_Final.pdf).
Centrifugation: Piece of equipment used to separate contained materials of
different specific gravities, or to separate colloidal particles suspended in a
liquid.
Closed system autoanalyser: An automated analysis machine where
specimens are uploaded and remain within the system during analysis
therefore greatly reducing or preventing the risk of infection to laboratory staff
via contact with the specimen.
Containment level 2 laboratory: Laboratory generally used for working with
Hazard Group 2 biological agents.
Containment level 3 laboratory: Laboratory generally used for working with
Hazard Group 3 biological agents.
Containment level 4 laboratory: Laboratory generally used for working with
Hazard Group 4 biological agents.
95
Droplets: A small indefinite quantity (usually of liquid). Droplets are larger
than aerosols, although the cut-off size between droplets and aerosols are
often debated between 5 and 10μm.
Dual infection: Patient infected with more than one infectious agent e.g.
Plasmodium falciparum and Ebola virus.
Endemic: Occurring in a particular region or population.
Epidemiology/epidemiological: The study of the occurrence and cause of
disease in populations.
Face fit testing: A method for testing that a tight fitting facepiece (i.e. full face
mask, half mask, or filtering facepiece – commonly known as a disposable
mask/respirator) correctly fits the wearer i.e. ensuring that the facepiece
matches the wearer’s facial features and seals adequately to the wearer’s
face so as to ensure that when donned accurately will confer the required
protection to the wearer. Note that fit testing is not required for surgical masks
as these are not respiratory protective devices.
Filtering facepiece: A particulate respirator (mask) with a filter as an integral
part of the facepiece or with the entire facepiece composed of the filtering
material.
Half-mask: A respirator that covers the user’s nose and mouth and is fitted
with either cartridges or canisters to filter particulates or vapours.
Hazard: The intrinsic danger associated with the nature of an object or a
substance, an activity or, in the context of this guidance, an infectious agent.
Hazard Group (for biological agents): The classification of a biological agent
based on it’s ability to cause disease by infection based on whether the agent
is pathogenic for humans, whether the agent is a hazard to employees,
whether the agent is transmissible to the community, and whether there is
effective treatment or prophylaxis available.
Hazard Group 4 pathogen: A biological agent that causes severe human
disease and is a serious hazard to employees. It is likely to spread to the
community and there is usually no effective prophylaxis or treatment available.
96
Healthcare worker: Clinical and other staff, including those in primary care,
who have regular, clinical contact with patients; Laboratory and other staff e.g.
mortuary staff, who have direct contact with potentially infectious specimens;
Non-clinical ancillary staff who may have social contact with patients, but not
usually of prolonged or close nature.
Host: An organism that is infected with or is fed upon by a parasitic or
pathogenic organism e.g. a virus. The host does not benefit and is often
harmed by the association.
Howie laboratory coat: A style of lab coat that provides extra protection to
the wearer. It has elasticated cuffs, mandarin collar and buttons usually on the
left flank so as to overlap the material across the centre of the torso to offer
extra protection against splash.
Negative pressure differential: The difference in pressure between one
room (e.g. isolation suite) and another (e.g. ante room), which is negative to
the standard room pressure (e.g. ward).
Negative pressure isolator (Trexler): A sealed envelope of transparent
flexible polyvinylchloride (PVC) film in the shape of a truncated tent inside
which a negative pressure is maintained.
Powered hood: A hood that completely covers at least the face (eyes, nose,
mouth and chin) head and neck and may also cover portions of the shoulders
and torso of the wearer. a power operated fan and one or more filters, which
should provide a flow of filtered ambient air to the wearer in excess of the
wearer’s demand, with the exhaled air being discharged outside the respirator
by exhalation valves or other outlets. There are different classifications of
powered hoods, which confer different levels of protection to the wearer.
Proper officer: In relation to a purpose and to an authority, an officer
appointed for that purpose by that authority.
Respirator: A protective mask with a filter that protects the face and lungs
against harmful aerosols.
Respiratory protective equipment: Personal protective equipment designed
to protect the respiratory tract of the wearer.
97
Risk: The probability that under certain circumstances, the hazard will be
expressed, in the context of this guidance, the likelihood that infection and
disease will occur.
Risk assessment: Describing and quantifying the risk associated with a
hazard.
Standard precautions: A set of precautions used in order to minimise the
risk of infection from a patient.
Terminal clean: A procedure required to ensure that an area has been
cleaned/decontaminated following discharge of a patient with an infection in
order to ensure a safe environment for the next patient.
Vector: Any agent (living or inanimate) that acts as an intermediate carrier or
alternative host for a pathogenic organism and transmits it to a susceptible
host.
VHF screen: Testing of a patient’s sample for the presence or absence of
VHF genetic material via PCR analysis.
Zoonosis: An infectious disease in animals that can be transmitted to people,
however, the natural reservoir for the infectious agent is an animal.
98
APPENDIX 15: ABBREVIATIONS
ACDP
ADR
APF
APTT
AST
BS
CCDC
CE
CK
CoSHH
CRP
CXR
ECDC
EDTA
EN
EWRS
FBC
FFP3
HEPA
PHE
HSE
HSENI
HLIU
HSWA
HTM
IATA
ICT
IDU
IHCD
IHR
ISO
LDH
LFTs
MSC
NaDCC
NaOCL
NaTHNaC
NHS
Advisory Committee on Dangerous Pathogens
The European Agreement concerning the International
Carriage of Dangerous Goods by Road
Assigned Protection Factor
Activated partial thromboplastin time
Aspartate transaminase
British Standard
Consultant in Communicable Disease Control
Conformité Européenne (European Conformity)
Creatine kinase
Control of Substances Hazardous to Health
C-Reactive Protein
Chest X-ray
European Centre for Disease Prevention and Control
Ethylenediaminetetraacetic acid
European PPE and RPE standards
Early warning and response system
Full blood count
Filtering facepiece type 3 (filtering efficiency of 99%)
High efficiency particulate air
Public Health England
Health and Safety Executive
Health and Safety Executive, Northern Ireland
High Level Isolation Unit
The Health and Safety at Work etc. Act
Health technical memorandum
International Air Transport Association
Incident control team
Infectious disease unit
Institute of Healthcare Development
International Health Regulations
International Organisation for Standardization
Lactate dehydrogenase
Liver function tests
Microbiological safety cabinet
Sodium dichloroisocyanurate
Sodium hypochlorite
National Travel Health Network and Centre
National Health Service
99
NI
N.O.S
O2
Northern Ireland
Not Otherwise Specified
Oxygen
P3
Particle filter (filtering efficiency of at least 99.95%)
Pa
PCR
ppm
PT
PPE
PUWER
RAF
RIDDOR
Pascals
Polymerase Chain Reaction
parts per million
Prothrombin time
Personal protective equipment
Provision and Use of Work Equipment Regulations
Royal Air Force
Reporting of Injuries, Diseases and Dangerous
Occurrences Regulations
Registered medical practitioner
Respiratory protective equipment
RMP
RPE
TH2
Turbo Hood type 2 (equivalent to the protection afforded
by an FFP3 respirator)
U&E
UK
UN
WEL
WHO
VHF
Urea and electrolytes
United Kingdom
United Nations
Workplace Exposure Limit
World Health Organisation
Viral haemorrhagic fever
100
APPENDIX 16: ACKNOWLEDGEMENTS
Dr Michael Jacobs
Royal Free London NHS Foundation Trust
Dr Anne Tunbridge
Sheffield Teaching Hospitals NHS
Foundation Trust
Dr Emma Aarons
Rare and Imported Pathogens Lab, PHE
Dr Rob Shorten
Central
Manchester
Foundation Trust
Professor Peter Chiodini
Hospital for Tropical Diseases,
Hospitals NHS Foundation Trust
Stephen Groves
NHS
Dr Tim Brooks
Public Health England
Dr Ian Cropley
Royal Free Hospital
Group Captain Andy Green
Ministry of Defence
Professor George Griffin
Advisory Committee on Dangerous
University
NHS
UCL
Pathogens
Dr Susan Hopkins
Royal Free Hospital
Mr Trevor Hubbard
London Ambulance Service
Dr Dilys Morgan
Public Health England
Dr Ed Ong
Newcastle General Hospital
Dr Michael Kidd
University College London
Secretariat
Dr Brian Crook
Health and Safety Laboratory
Mrs Catherine Makison Booth
Health and Safety Laboratory
Mr John Newbold
Health and Safety Executive
Mr Lee Wilson
Health and Safety Executive
Dr Ginny Belson
Public Health England
Dr Mariam Orme
Public Health England
101
102